FDA Medical Device Recalls (openFDA)
Fujifilm Medical Systems U.S.A., Inc.: Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
- Recall number
- Z-1599-2016
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Product
- Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
- Status
- Terminated
- Initiated
- 2016-04-01
- Posted
- not on file
- Terminated
- 2018-07-11
- Reason
- Reports of failure of the device's power supply.
- Root cause
- Device Design
- Action
- Fujifilm sent an Medical Device Correction letter dated March 22, 2016, via FedEx to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Instructions for turning the unit off when not in use as an interim action. FMSU will conduct a field replacement of the power supply in all installed units. For further questions, please call (888) 385-4633.
- Quantity
- 2,062 devices
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- All serial numbers.
- 510(k) numbers
- ["K944046"]
- PMA numbers
- not on file
- Product code
- IXW
- Firm FEI
- 1000513161
- Firm city
- Stamford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28