Device product
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.
Z-1487-2013
Product summary
- Firm
- AGFA Corp.
- Event
- Event 65223
- Status
- Terminated
- Classification
- Class II
- Quantity
- 104
- Official record key
device-enforcement:Z-1487-2013
Official wording
Reason: Customers could potentially experience intermittent, unintended and illogical movement when using the product.
Code information: Material numbers in US - 5Q82F, 5R75Q, 5Q8ZB, 5R77U & 58Q1D - Material numbers in Canada - 5R78W & 5R77U
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
Derived failure modes
-
Unknown
Customers could potentially experience intermittent, unintended and illogical movement when using the product.