Company: Philips Medical Systems
Date of Enforcement Report: 5/1/2002
Class: III
PRODUCT
Integris H5000, Angiographic X-ray system. Recall # Z-0924-2.
REASON
System may occasionally re-boot during a patient examination.
CODE
Units with SYSCO software version 11.1.2.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated November 14, 2001.,
Manufacturer: Philips Medical Systems Nederland, b.v 5680 Da Best,
Netherlands. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
171.
DISTRIBUTION
Nationwide.
