Company: Philips Medical Systems, Inc.
Date of Enforcement Report 5/27/2015
Class lI:
PRODUCT
Philips Healthcare DuraDiagnost X- Ray
Recall Number Z-1555-2015
REASON
The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Andover, MA 2/9/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3 DuraDiagnost
DISTRIBUTION
Worldwide
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