FDA Device Recall Z-1749-2022: FUJIFILM Healthcare Americas Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-1749-2022.

Recall Res Number

Z-1749-2022

Recalling Firm / Manufacturer

FUJIFILM Healthcare Americas Corporation

FEI Number

1000513161

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2022-07-12

Date Posted

N/A

Date Terminated

N/A

Product Code

JAK

Event Number

90751

Product Quantity

20 units

Product Description Surpria: Software Version V3.11, V3.22

Reason for Recall Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation

Action Details FujiFilm issued Urgent Medical Device Letter were sent via email on July 12, 2022, consignees without an email contact were notified via FedEx on July 12, 2022 and July 15, 2022. Letter states reason for recall, health risk and action to take: Until your upgrade is scheduled and completed, you can continue to safely use your CT system by following these additional instructions: 1. When entering alphabetic characters in the patient information, please enter them in capital letters (e.g. ready READY ) 2. Set Auto Capital Letter to ON in the Preference Settings window. This will convert all text to capital letters for certain patient information fields. 3. Please register the following information in capital letters, as Auto Capital Letter does not apply to the following fields: a. (0008,0050) Accession Number b. (0008,0090) Referring Physician s Name c. (0010,0010) Patient s Name d. (0010,0020) Patient ID e. (0010,4000) Patient Comments f. (0032,1032) Requesting Physician g. (0032,1033) Requesting Service h. (0032,1060) Requested Procedure Description i. (0032,1070) Requested Contrast Agent j. (0040,0006) Scheduled Performing Physician s Name Please complete and return the Field Action Verification Form attached on page 5 of this communication. Responding with the information requested is essential for ensuring appropriate action is taken. Fujifilm regrets any inconvenience this action may cause and appreciates your understanding and cooperation. Please contact our field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email at jeffrey.wan@fujifilm.com

Distribution Pattern US Nationwide Distribution

Code Information / Serial Numbers UDI: (01)04580292766601(11)200130(21)W5067(250)G560045319 (01)04580292766601(11)200220(21)W5068(250)G560048119 (01)04580292766601(11)200902(21)W5069(250)G560071519 (01)04580292766601(11)201210(21)W5070(250)G560075519 (01)04580292766601(11)201225(21)W5071(250)G1Z0040620 (01)04580292766601(11)210218(21)W5072(250)G1Z0063520 (01)04580292766601(11)210512(21)W5073(250)G1Z0244920 (01)04580292766601(11)210519(21)W5074(250)G1Z0048121 (01)04573596200520(11)210818(21)W5075(250)G1Z0083221 (01)04573596200520(11)210903(21)W5076(250)G1Z0094621 (01)04573596200520(11)210903(21)W5077(250)G1Z0094521 (01)04573596200520(11)210903(21)W5077(250)G1Z0094521 (01)04573596200520(11)211018(21)W5079(250)G1Z0123621 (01)04573596200520(11)211115(21)W5080(250)G1Z0190221 (01)04573596200520(11)211122(21)W5081(250)G1Z0190021 (01)04573596200520(11)211122(21)W5082(250)G1Z0190121 (01)04573596200520(11)211227(21)W5083(250)G1Z0190321 (01)04573596200520(11)211228(21)W5084(250)G1Z0210821 (01)04573596200520(11)220209(21)W5085(250)G1Z0210921 (01)04573596200520(11)220215(21)W5086(250)G1Z0211021 Serial Numbers: G560045319 G560048119 G560071519 G560075519 G1Z0040620 G1Z0063520 G1Z0244920 G1Z0048121 G1Z0083221 G1Z0094621 G1Z0094521 G1Z0115321 G1Z0123621 G1Z0190221 G1Z0190021 G1Z0190121 G1Z0190321 G1Z0210821 G1Z0210921 G1Z0211021

Related Establishments / Registrations

ALKEN, INC. D/B/A POLHEMUS Registration: 1000246715 View Registration
FUJIFILM Healthcare Americas Corporation Registration: 1000513161 View Registration
SIEMENS MEDICAL SOLUTIONS USA, INC. Registration: 1034973 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
TOYO MEDICAL CO. Registration: 1054713 View Registration
SYNTERMED, INC. Registration: 1066019 View Registration
IZI MEDICAL PRODUCTS LLC Registration: 1123169 View Registration
OMNIlifeScience, Inc. Registration: 1226188 View Registration
Carestream Health, Inc Registration: 1317307 View Registration
SIEMENS MEDICAL SOLUTIONS USA, INC. Registration: 1423253 View Registration
STRYKER CORP. Registration: 1811755 View Registration
Vonco Products, LLC Registration: 1834003 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
Isomedix Operations, Inc. Registration: 2030624 View Registration
Isomedix Operations Inc. Registration: 2032112 View Registration
GE MEDICAL SYSTEMS, LLC Registration: 2126677 View Registration
CANON MEDICAL INFORMATICS, INC. Registration: 2134213 View Registration
ACIST MEDICAL SYSTEMS, INC. Registration: 2134243 View Registration
INTRICON CORPORATION Registration: 2134850 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
Anholt Technologies Inc. Registration: 2247992 View Registration
Bayer Medical Care Inc. Registration: 2520313 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
FUJIFILM CORPORATION Registration: 3001722928 View Registration
J. MORITA MFG. CORP. Registration: 3002807636 View Registration
Siemens Healthineers AG Registration: 3002808157 View Registration
Sterigenics US LLC Registration: 3002907620 View Registration
Varian Medical Systems Imaging Laboratory GmbH Registration: 3003094912 View Registration
SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. Registration: 3003202425 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
NEUSOFT MEDICAL SYSTEMS CO., LTD. Registration: 3003575350 View Registration
Biomerics Alajuela Registration: 3003678543 View Registration
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3003768277 View Registration
LODOX SYSTEMS (PTY) LTD. Registration: 3003967489 View Registration
Bayer Medical Care Inc. Registration: 3004056159 View Registration
HORIZONS INTL. CORP. Registration: 3004083736 View Registration
Sony Corporation Registration: 3004091527 View Registration
Xoran Technologies, LLC Registration: 3004198450 View Registration
Bracco Injeneering S.A. Registration: 3004753774 View Registration
EDDA TECHNOLOGY, INC. Registration: 3004857110 View Registration
Samsung HME America, Inc. Registration: 3004938766 View Registration
Covidien llc Registration: 3004962788 View Registration
Siemens Healthineers AG Registration: 3004977335 View Registration
INVIA, LLC Registration: 3004993756 View Registration
RIVERAIN TECHNOLOGIES Registration: 3005156333 View Registration
BAY SHORE MEDICAL EQUIPMENT, LLC Registration: 3005810333 View Registration
METROPOLIS INTERNATIONAL, LLC Registration: 3005877899 View Registration
FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama Registration: 3005930550 View Registration
Spectrum Dynamics Medical Ltd. Registration: 3006209933 View Registration
GSELL MEDICAL PLASTICS AG Registration: 3006487372 View Registration
CEFLA S.C. Registration: 3006610845 View Registration
ZIOSOFT, INC. Registration: 3006621332 View Registration
Siemens Healthineers AG Varian Cancer Therapy (CTH) Registration: 3006894636 View Registration
IMAGING BIOMETRICS, LLC Registration: 3007225492 View Registration
VIDA DIAGNOSTICS Registration: 3007233544 View Registration
GEXPRO, a Division of REXEL USA, Inc. Registration: 3007545404 View Registration
AGITO MEDICAL Registration: 3007562060 View Registration
PULMONX, Corp. Registration: 3007797756 View Registration
Spectrum Dynamics Medical Inc. Registration: 3008007310 View Registration
MEDOS INTERNATIONAL SARL Registration: 3008114965 View Registration
GE Healthcare (China) Co., Ltd. Registration: 3008284470 View Registration
HM PRODUCT SOLUTIONS, LTD. Registration: 3008355361 View Registration
EvERX PTY LTD Registration: 3008496839 View Registration
LJ BUSINESS CORPORATION Registration: 3008632256 View Registration
NEUWAVE MEDICAL, INC. Registration: 3008769756 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
Philips Healthcare (Suzhou) Co., Ltd. Registration: 3009529630 View Registration
CurveBeam, LLC Registration: 3009543051 View Registration
KUEHNE GMBH Registration: 3009963139 View Registration
Varian Medical Systems Hungary Kft. Registration: 3010123525 View Registration
MOBIUS IMAGING, LLC Registration: 3010151377 View Registration
J. MORITA MFG. CORP., TOTTORI FACTORY Registration: 3010281549 View Registration
IMRIS Imaging, Inc. Registration: 3010326005 View Registration
Probo Medical Ltd Registration: 3010398867 View Registration
MEVIS MEDICAL SOLUTIONS AG Registration: 3010601176 View Registration
ARINETA LTD. Registration: 3010642685 View Registration
MAKAR CONSULTING PTY LTD Registration: 3010703925 View Registration
CIS COMPUTERISED IMAGING SERVICES PTY LTD Registration: 3010789868 View Registration
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. Registration: 3011015597 View Registration
Gyrus ACMI, Inc. Registration: 3011050570 View Registration
CLEAR GUIDE MEDICAL Registration: 3011396687 View Registration
Medical Resale PTY Limited Registration: 3011416394 View Registration
Merit Maquiladora Mexico, S. DE R.L. DE C.V. Registration: 3011642792 View Registration
FLUIDDA NV Registration: 3011786147 View Registration
CASCINATION Registration: 3011797532 View Registration
QISDA ELECTRONICS (SUZHOU) CO., LTD. Registration: 3011802799 View Registration
FAIR MEDICAL CO.,LTD Registration: 3011825597 View Registration
United Imaging Healthcare North America, Inc Registration: 3011950073 View Registration
ACIST EUROPE BV Registration: 3012044688 View Registration
ADVANCED IMAGING SERVICES, INC. Registration: 3012085143 View Registration
Siemens Healthcare Limited Registration: 3012127758 View Registration
Nano-X AI Ltd. Registration: 3012453401 View Registration
Philips Health Technology (China) Co., Ltd. Shenyang Branch Registration: 3012938564 View Registration
SUMITOMO MITSUI FINANCE AND LEASING CO., LTD. Registration: 3012939903 View Registration
Imaginalis S.r.l. Registration: 3012957335 View Registration
ISYS Medizintechnik GmbH Registration: 3013035022 View Registration
Repair Operations Center Registration: 3013679558 View Registration
iSYS Medizintechnik GmbH Registration: 3013847349 View Registration
M-SOLUTIONS INC. Registration: 3013875850 View Registration
FLEXRAY MEDICAL Registration: 3014134519 View Registration
Biomerics Cartago Registration: 3014246639 View Registration
EVERX JAPAN CO. LTD Registration: 3014343100 View Registration
THIRONA BV Registration: 3014653800 View Registration
UIH TECHNOLOGIES, LLC Registration: 3014809646 View Registration
AIDOC MEDICAL LTD. Registration: 3014938447 View Registration
IMACTIS, SAS Registration: 3015060224 View Registration
CORELINE SOFT CO., LTD. Registration: 3015169361 View Registration
ANDA Medical Registration: 3015223550 View Registration
ELEKTA SOLUTIONS AB Registration: 3015232217 View Registration
CAN TECHNOMED TRADING LTD. Registration: 3015276088 View Registration
CLARIPI INC. Registration: 3015537315 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
NVIEW MEDICAL Registration: 3016619943 View Registration
IB LAB GMBH Registration: 3016965352 View Registration
BRAINOMIX LIMITED Registration: 3017210169 View Registration
Scandinavian Medical Solutions A/S Registration: 3017375271 View Registration
Auris Health, Inc Registration: 3017425975 View Registration
4DMEDICAL LIMITED Registration: 3017426576 View Registration
LEO CANCER CARE INCORPORATED Registration: 3017500061 View Registration
Philips Ultrasound LLC Registration: 3017894900 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa Registration: 3018423337 View Registration
EPICA HUMAN HEALTH Registration: 3018596740 View Registration
Philips Ultrasound LLC Registration: 3019216 View Registration
MEDICAL IMAGING SALE AND SERVICE INC Registration: 3021059265 View Registration
BLOCK IMAGING SAS Registration: 3023003446 View Registration
QUANTUM SURGICAL SAS Registration: 3023140882 View Registration
Auris Health, Inc. Registration: 3023460764 View Registration
20MED PTE LTD Registration: 3026047529 View Registration
MEDICAPS CO., LTD. Registration: 3026391023 View Registration
ICAD INC. Registration: 3026970882 View Registration
BUNKERHILL HEALTH Registration: 3027245002 View Registration
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Registration: 3027338963 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
GE Medical Systems Israel, Functional Imaging Registration: 3033524251 View Registration
Philips Global Business Services LLP - Ultrasound Business Unit Registration: 3033527241 View Registration
Philips India Limited - Image Guided Therapy Systems Business Unit Registration: 3033527282 View Registration
Philips India Limited - Ultrasound Business Unit Registration: 3033527283 View Registration
PROBO MEDICAL SAS Registration: 3035950510 View Registration
FUJITA CO., LTD. Registration: 3036666444 View Registration
HEARTLUNG CORPORATION Registration: 3039211310 View Registration
NZ BIOMED LIMITED Registration: 3042172882 View Registration
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3042175844 View Registration
FIELD THREE CORPORATION Registration: 3043512431 View Registration
CHANGE HEALTHCARE CANADA COMPANY Registration: 8022257 View Registration
Planmed Oy Registration: 8043728 View Registration
BRAINLAB SE Registration: 8043933 View Registration
GE MEDICAL SYSTEMS SCS Registration: 9611343 View Registration
GE Healthcare Japan Corporation Registration: 9612283 View Registration
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Registration: 9613299 View Registration
GE HANGWEI MEDICAL SYSTEMS CO., LTD. Registration: 9613445 View Registration
CANON INC. Registration: 9614698 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9616567 View Registration
PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD. Registration: 9617978 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-1749-2022

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer