Recall Z-2176-2014 ยท IZL System, X-Ray, Mobile
AGFA Healthcare Corp.
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.
| Date | Aug 10, 2014 (initiated May 13, 2014) |
| Status | Terminated |
| Reason | Unit was mislabeled with a factory label showing 32 KW output power. |
| Root cause | Labeling mix-ups |
| Action | Only one customer was affected no customer letter was issued field correction was conducted.. |
| Quantity | 1 |
| Distribution | US in the state of WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103597 | DX-D 100 Agfa Healthcare N.V., Jan 3, 2011 |