CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate...

FDA Device Recall #Z-0970-2013 — Class II — February 7, 2013

Recall Summary

Recall Number Z-0970-2013
Classification Class II — Moderate risk
Date Initiated February 7, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm AGFA Corp.
Location Greenville, SC
Product Type Devices
Quantity 17

Product Description

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 for Recall

The cassettes were shipped with the wrong IP (image plate) size bar code.

Distribution Pattern

USA Nationwide Distribution including the states of: AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.

Lot / Code Information

Batch No. A2KQMW

Other Recalls from AGFA Corp.

Recall # Classification Product Date
Z-2081-2014 Class II AGFA Digital Radiography X-Ray system DX-D 100 ... Jun 6, 2014
Z-1662-2014 Class II IMPAX CV Pediatric Echo Reporting, IMPAX CV Ech... Apr 30, 2014
Z-0919-2014 Class II IMPAX RIS QDOC 5.8 Jan 8, 2014
Z-0035-2014 Class II IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0)... Sep 19, 2013
Z-1487-2013 Class II AGFA Digital Radiography X-Ray System DX-D 100 ... May 15, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.