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Recall Observatory FDA recall evidence

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

May 15, 2013

Class II

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

    reason.no_named_rule · v1.0.0

    Customers could potentially experience intermittent, unintended and illogical movement when using the product.