FDA Device Recall Z-0395-2024: Philips North America Llc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0395-2024.

Recall Res Number

Z-0395-2024

Recalling Firm / Manufacturer

Philips North America Llc

FEI Number

3016618143

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2023-10-23

Date Posted

2023-11-21

Date Terminated

N/A

Product Code

LNH

Event Number

93361

Product Quantity

119 units

Product Description SmartPath to dStream for 1.5T

Reason for Recall Potential component failure in the Gradient Coil could product smoke and/or fire.

Action Details The firm mailed URGENT Medical Device Correction Notices dated 10/23/2023 to consignees to notify them of this recall event. Consignees are instructed to identify if they possess any affected devices in their inventory and to follow the provided instructions for when scan aborts occur to prevent the failure mode associated with this recall event. Consignees are to stop the scan immediately and contact Philips Service if any of the failure situations outlined in the notice occur during a scan. Consignees are asked to complete and return the provided response form to Philips no later than 30 days after receipt of the recall notice. Questions can be directed to Customer Care Solutions at 1-800-722-9377.

Distribution Pattern Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.

Code Information / Serial Numbers Product No. 781260 & 782112; UDI-DI: (01)00884838095076(21)5447, (01)00884838095076(21)5463, (01)00884838095076(21)5479, (01)00884838095076(21)5490, (01)00884838095076(21)5537, (01)00884838095076(21)5546, (01)00884838095076(21)8012, (01)00884838095076(21)8025, (01)00884838095076(21)8054, (01)00884838095076(21)8086, (01)00884838095076(21)8087, (01)00884838095076(21)8091, (01)00884838095076(21)8092, (01)00884838095076(21)8110, (01)00884838095076(21)8118, (01)00884838095076(21)8178, (01)00884838095076(21)8260, (01)00884838095076(21)8311, (01)00884838095076(21)8318, (01)00884838095076(21)8365, (01)00884838095076(21)8378, (01)00884838095076(21)8387, (01)00884838095076(21)8392, (01)00884838095076(21)8395, (01)00884838095076(21)8427, (01)00884838095076(21)8554, (01)00884838095076(21)8566, (01)00884838095076(21)8578, (01)00884838095076(21)8611, (01)00884838095076(21)8616, (01)00884838095076(21)8639, (01)00884838095076(21)8642, (01)00884838095076(21)8667, (01)00884838095076(21)8706, (01)00884838095076(21)8713, (01)00884838095076(21)8746, (01)00884838095076(21)8750, (01)00884838095076(21)8752, (01)00884838095076(21)8779, (01)00884838095076(21)8783, (01)00884838095076(21)8786, (01)00884838095076(21)8831, (01)00884838095076(21)8840, (01)00884838095076(21)8851, (01)00884838095076(21)8857, (01)00884838095076(21)8884, (01)00884838095076(21)8895, (01)00884838095076(21)8896, (01)00884838095076(21)8923, (01)00884838095076(21)8942, (01)00884838095076(21)8948, (01)00884838095076(21)9004, (01)00884838095076(21)9013, (01)00884838095076(21)10029, (01)00884838095076(21)10044, (01)00884838095076(21)10075, (01)00884838095076(21)10079, (01)00884838095076(21)10130, (01)00884838095076(21)10151, (01)00884838095076(21)10164, (01)00884838095076(21)10170, (01)00884838095076(21)10174, (01)00884838095076(21)10185, (01)00884838095076(21)10191, (01)00884838095076(21)10458, (01)00884838095076(21)10511, (01)00884838095076(21)10513, (01)00884838095076(21)10554, (01)00884838095076(21)10906, (01)00884838095076(21)10915, (01)00884838095076(21)11031, (01)00884838095076(21)11047, (01)00884838095076(21)11062, (01)00884838095076(21)11076, (01)00884838095076(21)11085, (01)00884838095076(21)11091, (01)00884838095076(21)11102, (01)00884838095076(21)12030, (01)00884838095076(21)13011, (01)00884838095076(21)13029, (01)00884838095076(21)13032, (01)00884838095076(21)13062, (01)00884838095076(21)18038, (01)00884838095076(21)18670, (01)00884838095076(21)18761, (01)00884838095076(21)18957, (01)00884838095076(21)20071, (01)00884838095076(21)20111, (01)00884838095076(21)20226, (01)00884838095076(21)21062, (01)00884838095076(21)21213, (01)00884838095076(21)21576, (01)00884838095076(21)21582, (01)00884838095076(21)21801, (01)00884838095076(21)21814, (01)00884838095076(21)22013, (01)00884838095076(21)22017, (01)00884838095076(21)22031, (01)00884838095076(21)22086, (01)00884838095076(21)22098, (01)00884838095076(21)22102, (01)00884838095076(21)22144, (01)00884838095076(21)22157, (01)00884838095076(21)22248, (01)00884838095076(21)30033, (01)00884838095076(21)32218, (01)00884838095076(21)33044, (01)00884838095076(21)33246, (01)00884838095076(21)39003, (01)00884838095076(21)39024, (01)00884838095076(21)39031, (01)00884838095076(21)39037, (01)00884838095076(21)72054, (01)00884838095076(21)72243, (01)00884838095076(21)72250, (01)00884838098886(21)10128, (01)00884838098886(21)21893, (01)00884838098886(21)32580, (01)00884838098886(21)32798; Serial No. 5447, 5463, 5479, 5490, 5537, 5546, 8012, 8025, 8054, 8086, 8087, 8091, 8092, 8110, 8118, 8178, 8260, 8311, 8318, 8365, 8378, 8387, 8392, 8395, 8427, 8554, 8566, 8578, 8611, 8616, 8639, 8642, 8667, 8706, 8713, 8746, 8750, 8752, 8779, 8783, 8786, 8831, 8840, 8851, 8857, 8884, 8895, 8896, 8923, 8942, 8948, 9004, 9013, 10029, 10044, 10075, 10079, 10130, 10151, 10164, 10170, 10174, 10185, 10191, 10458, 10511, 10513, 10554, 10906, 10915, 11031, 11047, 11062, 11076, 11085, 11091, 11102, 12030, 13011, 13029, 13032, 13062, 18038, 18670, 18761, 18957, 20071, 20111, 20226, 21062, 21213, 21576, 21582, 21801, 21814, 22013, 22017, 22031, 22086, 22098, 22102, 22144, 22157, 22248, 30033, 32218, 33044, 33246, 39003, 39024, 39031, 39037, 72054, 72243, 72250, 10128, 21893, 32580, 32798.

Related Establishments / Registrations

SUN NUCLEAR CORPORATION Registration: 1038814 View Registration
TOYO MEDICAL CO. Registration: 1054713 View Registration
AVOTEC, INC. Registration: 1055916 View Registration
Sterigenics US LLC Registration: 1058584 View Registration
LifeSync Corporation Registration: 1063285 View Registration
IVY BIOMEDICAL SYSTEMS, INC. Registration: 1221108 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
Sterigenics US, LLC Registration: 1526534 View Registration
GE Healthcare Coils Registration: 1529041 View Registration
Isomedix Operations Inc. Registration: 1650907 View Registration
DIACOR, INC. Registration: 1721113 View Registration
MEDTRONIC NAVIGATION, INC. Registration: 1723170 View Registration
Esaote North America, Inc Registration: 1826555 View Registration
Creative Foam Corporation - Bremen Registration: 1835830 View Registration
MEDTEC LLC Registration: 1932738 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
RESONANCE TECHNOLOGY, INC. Registration: 2029299 View Registration
GE MEDICAL SYSTEMS, LLC Registration: 2126677 View Registration
CANON MEDICAL INFORMATICS, INC. Registration: 2134213 View Registration
GE MEDICAL SYSTEMS, LLC Registration: 2183553 View Registration
Anholt Technologies Inc. Registration: 2247992 View Registration
FONAR CORP. Registration: 2432211 View Registration
Bayer Medical Care Inc. Registration: 2520313 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
Siemens Healthineers AG Registration: 3002808157 View Registration
VASSOL, INC. Registration: 3003494057 View Registration
KLUGE DESIGN INC. Registration: 3003661577 View Registration
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3003768277 View Registration
GE HEALTHCARE Registration: 3004526608 View Registration
NOVA MEDICAL, INC Registration: 3004531751 View Registration
SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. Registration: 3004754211 View Registration
MRI DIVISION, Beijing Wandong Medical Technology Co.,Ltd Registration: 3004859018 View Registration
NORAS MRI products GMBH Registration: 3004929307 View Registration
Siemens Healthineers AG Registration: 3004977335 View Registration
ASG Superconductors S.p.A. Registration: 3004994584 View Registration
RAPID BIOMEDICAL GMBH Registration: 3005049692 View Registration
GE Healthcare Manufacturing LLC Registration: 3005326970 View Registration
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD Registration: 3005450718 View Registration
PRISM CLINICAL IMAGING, INC. Registration: 3005517190 View Registration
BAY SHORE MEDICAL EQUIPMENT, LLC Registration: 3005810333 View Registration
METROPOLIS INTERNATIONAL, LLC Registration: 3005877899 View Registration
OPTOACOUSTICS LTD. Registration: 3005976071 View Registration
Myocardial Solutions Registration: 3006015847 View Registration
CNMC CO., INC. Registration: 3006073271 View Registration
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD Registration: 3006239787 View Registration
EVOLVE MANUFACTURING TECHNOLOGIES INC. Registration: 3006262888 View Registration
NEOCOIL, LLC Registration: 3006369484 View Registration
ZIOSOFT, INC. Registration: 3006621332 View Registration
NORDICNEUROLAB AS Registration: 3006738448 View Registration
STERIL VERONA s.r.l. Registration: 3006849754 View Registration
QUALITY ELECTRODYNAMICS Registration: 3007350713 View Registration
GEXPRO, a Division of REXEL USA, Inc. Registration: 3007545404 View Registration
VIEWRAY SYSTEMS, INC. Registration: 3007546534 View Registration
AGITO MEDICAL Registration: 3007562060 View Registration
WIPRO GE HEALTHCARE PRIVATE Ltd. Registration: 3007734888 View Registration
XINGAOYI MEDICAL EQUIPMENT CO., LTD Registration: 3008156140 View Registration
GE Healthcare (China) Co., Ltd. Registration: 3008284470 View Registration
HM PRODUCT SOLUTIONS, LTD. Registration: 3008355361 View Registration
ELSMED LTD. Registration: 3008447096 View Registration
EvERX PTY LTD Registration: 3008496839 View Registration
LJ BUSINESS CORPORATION Registration: 3008632256 View Registration
BENCHMARK ELECTRONICS, INC. Registration: 3008986341 View Registration
DHL SUPPLY CHAIN (NETHERLANDS) B.V. Registration: 3009077524 View Registration
MEDICAL OUTFITTERS, INC Registration: 3009154005 View Registration
LBN MEDICAL A/S Registration: 3009196578 View Registration
Sterigenics Radiation Technologies IN, Inc Registration: 3009504230 View Registration
ASPECT IMAGING LTD Registration: 3009714754 View Registration
SG HEALTHCARE CO LTD Registration: 3009715136 View Registration
Shenzhen RF Tech Co., Ltd. Registration: 3009755250 View Registration
Synergy Health AST, LLC Registration: 3009882464 View Registration
KUEHNE GMBH Registration: 3009963139 View Registration
MULTISOURCE MANUFACTURING LLC Registration: 3010009632 View Registration
IMRIS Imaging, Inc. Registration: 3010326005 View Registration
Probo Medical Ltd Registration: 3010398867 View Registration
MACROMEDICS BV Registration: 3010701021 View Registration
MAKAR CONSULTING PTY LTD Registration: 3010703925 View Registration
GE HEALTHCARE (TIANJIN) COMPANY LIMITED Registration: 3010949642 View Registration
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. Registration: 3011015597 View Registration
TECMA OPERACIONES S. DE R.L. DE C.V. Registration: 3011106828 View Registration
Medical Resale PTY Limited Registration: 3011416394 View Registration
Brainreader Registration: 3011657336 View Registration
Vista AI Inc. Registration: 3011767965 View Registration
United Imaging Healthcare North America, Inc Registration: 3011950073 View Registration
Synaptive Medical Inc Registration: 3012075008 View Registration
ADVANCED IMAGING SERVICES, INC. Registration: 3012085143 View Registration
Siemens Healthcare Limited Registration: 3012127758 View Registration
SIARON MEDICAL LTD Registration: 3012169560 View Registration
JIANGSU MAGSPIN INSTRUMENT CO., LTD Registration: 3012354318 View Registration
SHANGHAI CHENSHI MEDICAL INSTRUMENTS CO., LTD Registration: 3012439308 View Registration
SUMITOMO MITSUI FINANCE AND LEASING CO., LTD. Registration: 3012939903 View Registration
Repair Operations Center Registration: 3013679558 View Registration
RESOUNDANT, INC. Registration: 3013695852 View Registration
M-SOLUTIONS INC. Registration: 3013875850 View Registration
SYNTHETICMR AB Registration: 3014111222 View Registration
PERSPECTUM LTD. Registration: 3014232555 View Registration
Hyperfine, Inc Registration: 3014310698 View Registration
EVERX JAPAN CO. LTD Registration: 3014343100 View Registration
PROMAXO, INC. Registration: 3014635027 View Registration
MRIAUDIO, INC. Registration: 3014680716 View Registration
UIH TECHNOLOGIES, LLC Registration: 3014809646 View Registration
ANDA Medical Registration: 3015223550 View Registration
ELEKTA SOLUTIONS AB Registration: 3015232217 View Registration
CAN TECHNOMED TRADING LTD. Registration: 3015276088 View Registration
GE Healthcare Manufacturing LLC Registration: 3015329423 View Registration
Subtle Medical Inc Registration: 3015425142 View Registration
DXTX MEDICAL INC. Registration: 3015431711 View Registration
MAGNETTX ONCOLOGY SOLUTIONS LTD Registration: 3016591365 View Registration
Philips North America LLC Registration: 3016618143 View Registration
HEURON CO., LTD. Registration: 3016727312 View Registration
Philips Global Business Services LLP Registration: 3016851825 View Registration
PRENUVO Inc. Registration: 3017297314 View Registration
Scandinavian Medical Solutions A/S Registration: 3017375271 View Registration
Turing Medical Technologies, Inc. Registration: 3017383732 View Registration
Philips Medical Systems (Cleveland), Inc. Registration: 3018004899 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa Registration: 3018423337 View Registration
NORTHH MEDICAL GMBH Registration: 3019595609 View Registration
TracInnovations A/S Registration: 3019844073 View Registration
SPINTECH, INC. Registration: 3020162557 View Registration
MEDICAL IMAGING SALE AND SERVICE INC Registration: 3021059265 View Registration
AMRA MEDICAL AB Registration: 3021593788 View Registration
BLOCK IMAGING SAS Registration: 3023003446 View Registration
Philips DS North America LLC Registration: 3023385454 View Registration
20MED PTE LTD Registration: 3026047529 View Registration
MEDICAPS CO., LTD. Registration: 3026391023 View Registration
SINO CANADA HEALTH ENGINEERING RESEARCH INSTITUTE (HEFEI) LTD. (SCHERI) Registration: 3027325776 View Registration
MEDIVEST GROUP Registration: 3027339477 View Registration
LIBERTY GLOBAL, LLC Registration: 3027373189 View Registration
BENELUX IMAGING Registration: 3029521953 View Registration
IONIC HEALTH TECHNOLOGIES SA Registration: 3030982377 View Registration
BLOCK IMAGING PARTS & SERVICE Registration: 3031503890 View Registration
WIPRO GE MEDICAL DEVICE MANUFACTURING PRIVATE LIMITED Registration: 3032109181 View Registration
FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office Registration: 3032109225 View Registration
SPRINGBOK ANALYTICS Registration: 3033333119 View Registration
Philips India Limited - Magnetic Resonance Business Unit Registration: 3033527281 View Registration
NEOSCAN SOLUTIONS GMBH Registration: 3033536331 View Registration
CIVCO Medical Instruments Co., Inc. Registration: 3034286426 View Registration
PROBO MEDICAL SAS Registration: 3035950510 View Registration
FUJITA CO., LTD. Registration: 3036666444 View Registration
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3042177665 View Registration
ESAOTE S.P.A. Registration: 8043485 View Registration
GE MEDICAL SYSTEMS SCS Registration: 9611343 View Registration
WIPRO GE HEALTHCARE PRIVATE LTD Registration: 9613936 View Registration
CANON INC. Registration: 9614698 View Registration
GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V. Registration: 9616047 View Registration
ELEKTA LIMITED Registration: 9617016 View Registration
Wipro GE Healthcare Private Ltd. Registration: 9617277 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0395-2024

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer