Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality image
FDA device recall Z-2176-2014 · posted 2014-08-10 · Terminated
Recall details
- Recalling firm
- AGFA Healthcare Corp.
- Reason for recall
- Unit was mislabeled with a factory label showing 32 KW output power.
- Action taken
- Only one customer was affected no customer letter was issued field correction was conducted..
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 1
- Distribution
- US in the state of WV
- Date initiated
- 2014-05-13
- Date posted
- 2014-08-10
- Date terminated
- 2014-08-13
- Location
- Greenville, SC
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DX-D 100 (K103597) | Agfa Healthcare N.V. | 2011-01-03 |