Z-1642-2014 Class II Terminated
FDA device recall Z-1642-2014 was initiated by Fujifilm Medical System USA, Inc. on June 29, 2012 and is designated Class II. 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. The recall status is terminated (terminated June 1, 2018). Affected quantity: 14.
Recall Details
- Product Type
- Devices
- Report Date
- May 28, 2014
- Initiation Date
- June 29, 2012
- Termination Date
- June 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14
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.
Distribution Pattern
Worldwide Distribution - US Distribution including the states of TX and KY and Internationally to China.
Code Information
SN: MXA1170108, MXA1270262