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.
This recall has been terminated (originally issued August 10, 2014).
- Company
- Agfa Healthcare Corp.
- Recall Initiated
- May 13, 2014
- Posted
- August 10, 2014
- Terminated
- August 13, 2014
- Recall Number
- Z-2176-2014
- Quantity
- 1
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
Reason for Recall
Unit was mislabeled with a factory label showing 32 KW output power.
Distribution
US in the state of WV
Lot / Code Info
Serial Number A5410000042
Root Cause
Labeling mix-ups
Action Taken
Only one customer was affected no customer letter was issued field correction was conducted..
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