Z-1599-2016 Class II Terminated
FDA device recall Z-1599-2016 was initiated by Fujifilm Medical Systems U.S.A., Inc. on Apr 1, 2016 and is designated Class II. Reason for recall: Reports of failure of the device's power supply. The recall status is terminated (terminated Jul 11, 2018). Affected quantity: 2,062 devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2016
- Initiation Date
- Apr 1, 2016
- Termination Date
- Jul 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,062 devices
Product Description
Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
Reason for Recall
Reports of failure of the device's power supply.
Distribution Pattern
Nationwide Distribution.
Code Information
All serial numbers.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1599-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026