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Recall Observatory FDA recall evidence

Device product

Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM

Z-0804-2015

October 24, 2014

Class III

Product summary

Firm
AGFA Healthcare Corp.
Event
Event 69864
Status
Terminated
Classification
Class III
Quantity
142 units
Official record key
device-enforcement:Z-0804-2015

Official wording

Reason: Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.

Code information: Lot 79440009

Distribution pattern: US Nationwide Distribution in the states of: AL, AZ, CA, LA, MI, NE, NH, NJ, NC, VA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.