FDA Device Recall Z-3158-2024: FUJIFILM Healthcare Americas Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-3158-2024.

Recall Res Number

Z-3158-2024

Recalling Firm / Manufacturer

FUJIFILM Healthcare Americas Corporation

FEI Number

1000513161

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2023-11-23

Date Posted

2024-09-25

Date Terminated

N/A

Product Code

IZL

Event Number

95320

Product Quantity

130

Product Description The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.

Reason for Recall When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.

Action Details Customer and Dealer notification will occur by means of letters alerting customers and dealers to the potential for overexposure to children if the conditions are not checked after the key switch is turned on. The notices also include the plan for the affected mobile x-ray systems. The system will be upgraded, free of charge, with updated software so that the exposure values set by the user are reflected regardless of the state of the key switch.

Distribution Pattern US Nationwide and Worldwide

Code Information / Serial Numbers All serial numbers shipped from FUJIFILM

Related Establishments / Registrations

FUJIFILM Healthcare Americas Corporation Registration: 1000513161 View Registration
HUESTIS MACHINE CORP. Registration: 1219183 View Registration
REMOTE TECHNOLOGIES, INC. Registration: 1222777 View Registration
UMI INTL. Registration: 1225677 View Registration
Carestream Health, Inc Registration: 1317307 View Registration
X-CEL X-RAY CORP. Registration: 1418484 View Registration
MINXRAY, INC. Registration: 1418960 View Registration
DEL MEDICAL, INC. Registration: 1418964 View Registration
GE MEDICAL SYSTEMS, LLC Registration: 2126677 View Registration
MEDLINK IMAGING, LLC. Registration: 2433615 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
AGFA N.V. Registration: 3001556265 View Registration
FUJIFILM CORPORATION Registration: 3001722928 View Registration
SOYEE PRODUCT, INC. Registration: 3002707445 View Registration
Philips Medical Systems DMC GmbH Registration: 3003768251 View Registration
FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office Registration: 3003775006 View Registration
FIRST SOURCE INC. Registration: 3004063527 View Registration
Source-Ray, Inc. Registration: 3004606964 View Registration
VATECH CO., LTD. Registration: 3004706313 View Registration
Siemens Healthineers AG Registration: 3004977335 View Registration
POSKOM CO., LTD Registration: 3005246977 View Registration
BAY SHORE MEDICAL EQUIPMENT, LLC Registration: 3005810333 View Registration
METROPOLIS INTERNATIONAL, LLC Registration: 3005877899 View Registration
Kub Technologies, Inc. Registration: 3006051164 View Registration
OEHM UND REHBEIN GMBH Registration: 3006542593 View Registration
DRGEM CORPORATION Registration: 3006551157 View Registration
DEXCOWIN CO., LTD. Registration: 3007065358 View Registration
WIPRO GE HEALTHCARE PRIVATE Ltd. Registration: 3007734888 View Registration
HOSMED INC. Registration: 3007836437 View Registration
TECHNIX SPA Registration: 3008044777 View Registration
GE Healthcare (China) Co., Ltd. Registration: 3008284470 View Registration
EvERX PTY LTD Registration: 3008496839 View Registration
SKANRAY TECHNOLOGIES LIMITED Registration: 3009001657 View Registration
DHL SUPPLY CHAIN (NETHERLANDS) B.V. Registration: 3009077524 View Registration
RadmediX, LLC Registration: 3009134655 View Registration
SG HEALTHCARE CO LTD Registration: 3009715136 View Registration
Samsung Electronics Co., Ltd. Registration: 3010300212 View Registration
Probo Medical Ltd Registration: 3010398867 View Registration
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. Registration: 3011015597 View Registration
Medical Resale PTY Limited Registration: 3011416394 View Registration
ECOTRON Co., Ltd. Registration: 3011491794 View Registration
United Imaging Healthcare North America, Inc Registration: 3011950073 View Registration
Siemens Healthcare Limited Registration: 3012127758 View Registration
ASPEN IMAGING HEALTHCARE, INC Registration: 3012624817 View Registration
MICRO-X LTD Registration: 3012855798 View Registration
SOLUTIONS FOR TOMORROW AB Registration: 3013677815 View Registration
Repair Operations Center Registration: 3013679558 View Registration
REMEDI INC. Registration: 3013779985 View Registration
LIVERMORETECH,INC Registration: 3014209556 View Registration
DK MEDICAL SYSTEMS CO., LTD. Registration: 3014403439 View Registration
UIH TECHNOLOGIES, LLC Registration: 3014809646 View Registration
ANDA Medical Registration: 3015223550 View Registration
CAN TECHNOMED TRADING LTD. Registration: 3015276088 View Registration
VSI CO., LTD. Registration: 3015502499 View Registration
OTOM Co., Ltd. Registration: 3015537309 View Registration
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED Registration: 3016250464 View Registration
H&ABYZ Registration: 3016674851 View Registration
Scandinavian Medical Solutions A/S Registration: 3017375271 View Registration
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. Registration: 3017944270 View Registration
OXOS MEDICAL, INC Registration: 3018077344 View Registration
SUZHOU POWERSITE ELECTRIC CO., LTD. Registration: 3018269927 View Registration
NEUF Inc. Registration: 3021006193 View Registration
BLOCK IMAGING SAS Registration: 3023003446 View Registration
FSK CO., LTD Registration: 3023344919 View Registration
DRTECH CORPORATION Registration: 3024891354 View Registration
QPIX SOLUTIONS, INC. Registration: 3025442726 View Registration
DRGEM Corporation (Gimcheon Factory) Registration: 3029916061 View Registration
BLOCK IMAGING PARTS & SERVICE Registration: 3031503890 View Registration
SAMSUNG ELECTRONICS CO., LTD. Registration: 3032116890 View Registration
Philips India Limited - Diagnostic X-ray Business Unit Registration: 3033525986 View Registration
Philips India Limited - Diagnostic X-ray Business Unit Registration: 3033527770 View Registration
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Registration: 8030233 View Registration
MIKASA X-RAY CO., LTD. Registration: 9610982 View Registration
GE HANGWEI MEDICAL SYSTEMS CO., LTD. Registration: 9613445 View Registration
SWISSRAY Medical, AG Registration: 9614430 View Registration
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. Registration: 9615439 View Registration
GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V. Registration: 9616047 View Registration
SEDECAL S.A. Registration: 9617251 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-3158-2024

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer