FDAFDA · Food and drugs·Recall number Z-1642-2014
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Published May 28, 2014 · Recall initiated: June 29, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fujifilm Medical System USA, Inc.
- Distributor
- Worldwide Distribution - US Distribution including the states of TX and KY and Internationally to China.
- Lot
- SN: MXA1170108, MXA1270262
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.