FDAFDA · Food and drugs·Recall number Z-2176-2014
Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
Published August 20, 2014 · Recall initiated: May 13, 2014
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
Unit was mislabeled with a factory label showing 32 KW output power.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- AGFA Healthcare Corp.
- Distributor
- US in the state of WV
- Lot
- Serial Number A5410000042
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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