Recall Z-1642-2014— Fujifilm Medical System USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Fujifilm Medical System USA, Inc., initiated 2012-06-29, terminated 2018-06-01. FDA's recall record names no specific 510(k) clearance for this event. Product: MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator. Reason: The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2..
- Recalling firm
- Fujifilm Medical System USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-06-29
- Terminated
- 2018-06-01
- Firm location
- Stamford, CT, United States
Product description
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Reason for recall
The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.
Data sourced from openFDA. This site is unofficial and independent of the FDA.