Company: Philips Healthcare
Date of Enforcement Report 6/15/2016
Class lI:
PRODUCT
Philips Healthcare DigitalDiagnost stationary X-ray system.
Recall Number Z-1695-2016
REASON
The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
RECALLING FIRM/MANUFACTURER
Philips Healthcare, Andover, MA on 11/10/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
160
DISTRIBUTION
Nationwidewide
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