Z-1487-2013 Class II Terminated
FDA device recall Z-1487-2013 was initiated by AGFA Corp. on May 15, 2013 and is designated Class II. Reason for recall: Customers could potentially experience intermittent, unintended and illogical movement when using the product. The recall status is terminated (terminated December 31, 2014). Affected quantity: 104.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2013
- Initiation Date
- May 15, 2013
- Termination Date
- December 31, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 104
Product Description
AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.
Reason for Recall
Customers could potentially experience intermittent, unintended and illogical movement when using the product.
Distribution Pattern
Worldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of Canada
Code Information
Material numbers in US - 5Q82F, 5R75Q, 5Q8ZB, 5R77U & 58Q1D - Material numbers in Canada - 5R78W & 5R77U