FDA Device Recall Z-0013-2007: Philips Medical Systems (Cleveland) Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0013-2007.

Recall Res Number

Z-0013-2007

Recalling Firm / Manufacturer

Philips Medical Systems (Cleveland) Inc

FEI Number

1525965

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-11-06

Date Posted

2007-09-26

Date Terminated

2010-10-05

Product Code

KPS

Event Number

37567

Product Quantity

Product Description Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems.

Reason for Recall A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator.

Action Details The customers were sent Public Safety Notification November 3, 2006, indicating there was a problem with the software. However, since their unit was recently upgraded the problem did not impact their unit.

Distribution Pattern Worldwide, including USA, Australia, Canada, China, England, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Netherlands, Poland, Puerto Rico, Spain, and Taiwan.

Code Information / Serial Numbers Serial #s: 4034-4100, 4102, 4103, 1041

Related Establishments / Registrations

SIEMENS MEDICAL SOLUTIONS USA, INC. Registration: 1034973 View Registration
SYNTERMED, INC. Registration: 1066019 View Registration
SIEMENS MEDICAL SOLUTIONS USA, INC. Registration: 1423253 View Registration
MIE AMERICA, INC. Registration: 1423348 View Registration
Isomedix Operations, Inc. Registration: 1424263 View Registration
Isomedix Operations, Inc. Registration: 1450662 View Registration
MEDIMAGE, INC. Registration: 1833124 View Registration
Digirad Diagnostic Imaging, LLC Registration: 2031050 View Registration
GE MEDICAL SYSTEMS, LLC Registration: 2126677 View Registration
CANON MEDICAL INFORMATICS, INC. Registration: 2134213 View Registration
Anholt Technologies Inc. Registration: 2247992 View Registration
RBM SERVICES, LLC. Registration: 2320968 View Registration
E-Z-EM, INC. Registration: 2411512 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
Philips Medical Systems Nederland B.V. Registration: 3000976525 View Registration
Siemens Healthineers AG Registration: 3002808157 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC Registration: 3004504920 View Registration
SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. Registration: 3004754211 View Registration
INVIA, LLC Registration: 3004993756 View Registration
MIE GMBH Registration: 3005128583 View Registration
BAY SHORE MEDICAL EQUIPMENT, LLC Registration: 3005810333 View Registration
METROPOLIS INTERNATIONAL, LLC Registration: 3005877899 View Registration
CMR NAVISCAN CORPORATION Registration: 3005945241 View Registration
Spectrum Dynamics Medical Ltd. Registration: 3006209933 View Registration
INTER MEDICAL MEDIZINTECHNIK GMBH Registration: 3006611212 View Registration
GEXPRO, a Division of REXEL USA, Inc. Registration: 3007545404 View Registration
NEUSOFT POSITRON MEDICAL SYSTEMS CO.,LTD. Registration: 3007675950 View Registration
Spectrum Dynamics Medical Inc. Registration: 3008007310 View Registration
HM PRODUCT SOLUTIONS, LTD. Registration: 3008355361 View Registration
EvERX PTY LTD Registration: 3008496839 View Registration
LJ BUSINESS CORPORATION Registration: 3008632256 View Registration
GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A. Registration: 3008962177 View Registration
CEDARS SINAI MEDICAL CENTER Registration: 3009136051 View Registration
LBN MEDICAL A/S Registration: 3009196578 View Registration
Philips Healthcare (Suzhou) Co., Ltd. Registration: 3009529630 View Registration
KUEHNE GMBH Registration: 3009963139 View Registration
Probo Medical Ltd Registration: 3010398867 View Registration
MAKAR CONSULTING PTY LTD Registration: 3010703925 View Registration
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. Registration: 3011015597 View Registration
Medical Resale PTY Limited Registration: 3011416394 View Registration
United Imaging Healthcare North America, Inc Registration: 3011950073 View Registration
ADVANCED IMAGING SERVICES, INC. Registration: 3012085143 View Registration
SIRTEX MEDICAL INC. Registration: 3012690638 View Registration
Repair Operations Center Registration: 3013679558 View Registration
FLEXRAY MEDICAL Registration: 3014134519 View Registration
EVERX JAPAN CO. LTD Registration: 3014343100 View Registration
COMBINOSTICS Registration: 3014470527 View Registration
UIH TECHNOLOGIES, LLC Registration: 3014809646 View Registration
CONVERGENT IMAGING SOLUTIONS Registration: 3014954414 View Registration
ELEKTA SOLUTIONS AB Registration: 3015232217 View Registration
CAN TECHNOMED TRADING LTD. Registration: 3015276088 View Registration
Subtle Medical Inc Registration: 3015425142 View Registration
Philips Medical Systems Technologies Ltd. Registration: 3015763655 View Registration
Philips Medical Systems Nederland B.V. Registration: 3015777306 View Registration
MULTIFUNCTIONAL IMAGING LLC Registration: 3016007746 View Registration
Scandinavian Medical Solutions A/S Registration: 3017375271 View Registration
ULTRASPECT USA, LLC Registration: 3018788582 View Registration
EverFortune.AI Co., Ltd. Registration: 3021032044 View Registration
MEDICAL IMAGING SALE AND SERVICE INC Registration: 3021059265 View Registration
RADIALIS INC. Registration: 3022742930 View Registration
BLOCK IMAGING SAS Registration: 3023003446 View Registration
20MED PTE LTD Registration: 3026047529 View Registration
MEDICAPS CO., LTD. Registration: 3026391023 View Registration
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Registration: 3027338963 View Registration
MEDIVEST GROUP Registration: 3027339477 View Registration
BENELUX IMAGING Registration: 3029521953 View Registration
X3D APS Registration: 3030186509 View Registration
DIGIT SYSTEMS SPA Registration: 3030210400 View Registration
IONIC HEALTH TECHNOLOGIES SA Registration: 3030982377 View Registration
BLOCK IMAGING PARTS & SERVICE Registration: 3031503890 View Registration
POSITRIGO AG Registration: 3032577207 View Registration
GE Medical Systems Israel, Functional Imaging Registration: 3033524251 View Registration
BRIGHTONIX IMAGING INC. Registration: 3034246184 View Registration
PROBO MEDICAL SAS Registration: 3035950510 View Registration
FUJITA CO., LTD. Registration: 3036666444 View Registration
CHANGE HEALTHCARE CANADA COMPANY Registration: 8022257 View Registration
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Registration: 8030233 View Registration
GE MEDICAL SYSTEMS SCS Registration: 9611343 View Registration
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Registration: 9613299 View Registration
GE HANGWEI MEDICAL SYSTEMS CO., LTD. Registration: 9613445 View Registration
WIPRO GE HEALTHCARE PRIVATE LTD Registration: 9613936 View Registration
CANON INC. Registration: 9614698 View Registration
PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD. Registration: 9617978 View Registration
HERMES MEDICAL SOLUTIONS, AB Registration: 9710645 View Registration

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Medical Device Recall: Z-0013-2007

Recall Parameters & Description

Related Establishments / Registrations

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