FDA Device Recall Z-0044-2026: FUJIFILM Healthcare Americas Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0044-2026.

Recall Res Number

Z-0044-2026

Recalling Firm / Manufacturer

FUJIFILM Healthcare Americas Corporation

FEI Number

1000513161

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2025-09-15

Date Posted

2025-10-07

Date Terminated

N/A

Product Code

KPR

Event Number

97581

Product Quantity

16 units

Product Description FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33

Reason for Recall It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.

Action Details On September, 15, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: Perform the daily inspection described in the operation manual to check for wobbles or shakes, misalignment of the light irradiation position, etc. If any abnormality is found, discontinue use and contact Technical Assistance Center (TAC). When rotating the X-ray tube unit, do not hit the stopper at the end. Do not rotate the X-ray tube over or near the patient. Please post this notice on or near the device. Complete and return the response form provided. Fujifilm Service Engineers will install countermeasure parts that will prevent the X-ray tube support from coming off even if the shaft is damaged. Please contact Technical Assistance Center (TAC) at 1-888-385-4633 or 1-888-FUJIMED for any functional/correction questions as well as to schedule your correction.

Distribution Pattern Domestic: AK, CA, FL, IL, MA, NH, OH, WI.

Code Information / Serial Numbers Model/Version Number: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33; UDI-DI: (1) 04540217052226, (2) 04540217057436, (3) 04540217057450; Serial Numbers: (1) MP95A8F5A001, MP95A9F6A001, MP95A9F6B001, MP95A9F74001, MP95A9F74002, MP95A9F76001, MP95A9F78001, (2) MP95AA783001, (3) MP95AA983001, MP95AA983002, MP95AA983003, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA988002;

Related Establishments / Registrations

FUJIFILM Healthcare Americas Corporation Registration: 1000513161 View Registration
TOYO MEDICAL CO. Registration: 1054713 View Registration
Konica Minolta Healthcare Americas, Inc Registration: 1064396 View Registration
Carestream Health, Inc Registration: 1317307 View Registration
X-CEL X-RAY CORP. Registration: 1418484 View Registration
DEL MEDICAL, INC. Registration: 1418964 View Registration
SUMMIT INDUSTRIES, LLC Registration: 1450503 View Registration
GE MEDICAL SYSTEMS, LLC Registration: 2126677 View Registration
Accogent Pausch Registration: 2243057 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
SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. Registration: 3003202425 View Registration
Philips Medical Systems DMC GmbH Registration: 3003768251 View Registration
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3003768277 View Registration
KONICA MINOLTA, INC. Registration: 3003769120 View Registration
FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office Registration: 3003775006 View Registration
THALES AVS FRANCE SAS Registration: 3004077520 View Registration
Xoran Technologies, LLC Registration: 3004198450 View Registration
KONICA MINOLTA, INC. Registration: 3004485675 View Registration
Source-Ray, Inc. Registration: 3004606964 View Registration
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V. Registration: 3004756607 View Registration
Siemens Healthineers AG Registration: 3004977335 View Registration
MEDICATECH USA Registration: 3004989804 View Registration
DRTECH Corporation Registration: 3005172103 View Registration
KONICA MINOLTA TECHNOPRODUCTS CO., LTD. Registration: 3005406110 View Registration
CARESTREAM HEALTH, INC., GLOBAL R&D CENTER Registration: 3005778458 View Registration
BAY SHORE MEDICAL EQUIPMENT, LLC Registration: 3005810333 View Registration
Kub Technologies, Inc. Registration: 3006051164 View Registration
JPI Healthcare Co., Ltd Registration: 3006115340 View Registration
EOS imaging Registration: 3006165260 View Registration
DRGEM CORPORATION Registration: 3006551157 View Registration
HALIFAX BIOMEDICAL INC. Registration: 3007305589 View Registration
GE Healthcare (China) Co., Ltd. Registration: 3008284470 View Registration
CUATTRO IMAGING, LLC Registration: 3008364043 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
Philips Healthcare (Suzhou) Co., Ltd. Registration: 3009529630 View Registration
ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. Registration: 3009608361 View Registration
SG HEALTHCARE CO LTD Registration: 3009715136 View Registration
KUEHNE GMBH Registration: 3009963139 View Registration
Samsung Electronics Co., Ltd. Registration: 3010300212 View Registration
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. Registration: 3011015597 View Registration
Medical Resale PTY Limited Registration: 3011416394 View Registration
FAIR MEDICAL CO.,LTD Registration: 3011825597 View Registration
United Imaging Healthcare North America, Inc Registration: 3011950073 View Registration
DAEIL PRECISION INDUSTRY CO.,LTD Registration: 3011955679 View Registration
VISARIS D.O.O. Registration: 3012569470 View Registration
ASPEN IMAGING HEALTHCARE, INC Registration: 3012624817 View Registration
Repair Operations Center Registration: 3013679558 View Registration
BIOKINEMETRICS INC. Registration: 3013714596 View Registration
LIVERMORETECH,INC Registration: 3014209556 View Registration
NANORAY BIOTECH CO., LTD. Registration: 3014293172 View Registration
DK MEDICAL SYSTEMS CO., LTD. Registration: 3014403439 View Registration
CAN TECHNOMED TRADING LTD. Registration: 3015276088 View Registration
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED Registration: 3016250464 View Registration
H&ABYZ Registration: 3016674851 View Registration
MEDICAL IMAGING SALE AND SERVICE INC Registration: 3021059265 View Registration
BLOCK IMAGING SAS Registration: 3023003446 View Registration
XERA Medikal Sistemleri ve Teknoloji Ltd. Sti. Registration: 3023190435 View Registration
DRTECH CORPORATION Registration: 3024891354 View Registration
QPIX SOLUTIONS, INC. Registration: 3025442726 View Registration
MEDIVEST GROUP Registration: 3027339477 View Registration
DRGEM Corporation (Gimcheon Factory) Registration: 3029916061 View Registration
GEMSS HEALTHCARE CO., LTD. Registration: 3030089787 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
PROBO MEDICAL SAS Registration: 3035950510 View Registration
OWO IMAGING LLC Registration: 3042864600 View Registration
OCTOSTOP, INC. Registration: 8022065 View Registration
CMT MEDICAL TECHNOLOGIES, LTD. Registration: 8030112 View Registration
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Registration: 8030233 View Registration
GE HANGWEI MEDICAL SYSTEMS CO., LTD. Registration: 9613445 View Registration
SWISSRAY Medical, AG Registration: 9614430 View Registration
ARCOMA AB Registration: 9616014 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-0044-2026

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer