CLASS II Device recall · Reported 27 Mar 2013 · FDA Enforcement Report
CR MD1.0 General Set, x-ray imager image plate recalled by AGFA
AGFA is recalling CR MD1.0 General Set, x-ray imager image plate, distributed nationwide in the US. The recall was initiated on 7 Feb 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0970-2013
- FDA event ID
- 64529
- Recalling firm
- AGFA, Greenville, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2013
- FDA classified
- 18 Mar 2013
- Reported
- 27 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 7 Feb 2013 | Recall initiated by company | |
| 18 Mar 2013 | Classified by FDA | +39 days |
| 27 Mar 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The cassettes were shipped with the wrong IP (image plate) size bar code.
Product as listed by the FDA
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.
Where it was distributed
USA Nationwide Distribution including the states of: AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.
Nationwide AlabamaCaliforniaFloridaIndianaMinnesotaNebraskaNevadaOhioSouth CarolinaUtah
Questions about this recall
Is CR MD1.0 General Set, x-ray imager image plate recalled?
Yes. AGFA recalled CR MD1.0 General Set, x-ray imager image plate on 7 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-0970-2013.
Why was it recalled?
The cassettes were shipped with the wrong IP (image plate) size bar code.
Which lots are affected?
Batch No. A2KQMW
Where was it sold?
USA Nationwide Distribution including the states of: AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from AGFA
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Digital Radiography X-Ray system Dx-d 100 Agfa's Dx-d recalled | AGFA | Other | Nationwide |
| Device | CLASS II | Impax CV Pediatric Echo Reporting recalled by AGFA | AGFA | Device Malfunction | SC |
| Device | CLASS II | Impax Ris Qdoc recalled by AGFA | AGFA | Other | 9 states |
| Device | CLASS II | Impax 2 DB Server (running Oracle 1.0.4.0) recalled by AGFA | AGFA | Device Malfunction | Nationwide |
| Device | CLASS II | Digital Radiography X-Ray System Dx-d 100 Agfa's Dx-d recalled | AGFA | Other | Nationwide |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled | Canon Medical System, USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederland B.v | Lead & Heavy Metals |