FDA Device recall 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 physic…
- FDA Device
- Class III
- terminated
- Published 2014-08-20
On 2014-08-20 the FDA classified a Class III recall of Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physic… by Agfa Healthcare, citing unit was mislabeled with a factory label showing 32 KW output power.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2176-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-05-13 |
| Published | 2014-08-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Agfa Healthcare |
| Distribution | WV |
Product
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.
Reason
Unit was mislabeled with a factory label showing 32 KW output power.
Identifiers
| code_info | Serial Number A5410000042 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2176-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.