FDA Device recall Z-0970-2013
CR MD1.0 General Set, x-ray imager image plate
- FDA Device
- Class II
- terminated
- Published 2013-03-27
On 2013-03-27 the FDA classified a Class II recall of CR MD1.0 General Set, x-ray imager image plate by Agfa, citing the cassettes were shipped with the wrong IP (image plate) size bar code.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0970-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-07 |
| Published | 2013-03-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Agfa |
| Distribution | US |
Product
CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing.
Reason
The cassettes were shipped with the wrong IP (image plate) size bar code.
Identifiers
| code_info | Batch No. A2KQMW |
|---|
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-0970-2013%22
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