Company: Philips Electronics North America Corporation
Date of Enforcement Report 12/23/2015
Class lI:
PRODUCT
Philips Healthcare Ingenuity CT Computed Tomography X-ray system
Recall Number Z-0408-2016
REASON
During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
RECALLING FIRM/MANUFACTURER
Philips Electronics North America Corporation, Andover, MA on 4/4/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
105
DISTRIBUTION
Worldwide
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