MXR-35 Diagnostic X-ray High Voltage Generator recall: Labeling Error
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Why was MXR-35 Diagnostic X-ray High Voltage Generator recalled?
The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SN: MXA1170108, MXA1270262
- Product
- MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
- Recalling firm
- Fujifilm Medical System USA, Inc.
- Quantity
- 14
- Distribution
- Worldwide Distribution - US Distribution including the states of TX and KY and Internationally to China.
- Recall date
- May 28, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)