FUJIFILM Healthcare Americas Corporation recalls Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
The incorrect computed patient age is showing in VX for patients less than 3 months old.
Read the official notice →- Date
- 2025-03-26
- Country
- United States
- Brand
- FUJIFILM Healthcare Americas
- Product
- Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
- Classification
- Class II
- Units
- Domestic: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MN, MO, MS,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More FUJIFILM Healthcare Americas recalls
- 2026-02-11
USFUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even…
FDA · DeviceFUJIFILM Healthcare Americas CorporationUS Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.Official notice →- 2025-10-15
- US
FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
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…
FDA · DeviceFUJIFILM Healthcare Americas CorporationDomestic: AK, CA, FL, IL, MA, NH, OH, WI.Official notice → - 2025-08-06
- US
FUJIFILM Healthcare Americas Corporation recalls ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast…
Devices had an unapproved slabbing software function enabled for use.
FDA · DeviceFUJIFILM Healthcare Americas CorporationWorldwide distribution - US Nationwide and the countries of Canada, Chile,…Official notice → - 2024-10-02
- US
FUJIFILM Healthcare Americas Corporation recalls The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID)…
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…
- 2024-06-05
- US
FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column,…
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
FDA · DeviceFUJIFILM Healthcare Americas CorporationUS Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.Official notice → - 2024-05-29
- US
FUJIFILM Healthcare Americas Corporation recalls Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
Other drugs & medical recalls in the United States
- 2025-04-02
- US
- US
Strides Pharma, Inc. recalls Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC…
Presence of foreign substance: Presence of Benzene.
- US
- 2025-03-26
- US
American Contract Systems Inc recalls CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.
- US
Smiths Medical ASD, Inc. recalls CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway…
FDA · DeviceSmiths Medical ASD, Inc.US Nationwide distribution. International distribution pending.Official notice → - US
ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY recalls Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis,…
Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension…
FDA · DeviceZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAYUS distribution nationwide. International distribution to Dominican Republic,…Official notice →