Company: Philips Medical Systems
Date of Enforcement Report: 1/8/2003
Class: II
PRODUCT
AXIS/IRIX Gamma Camera System, controlled with Odyssey computers, operating with version 8.5 software. Recall # Z-0353-3/Z-0364-3. The systems are controlled with Odyssey computers that are connected to a Prism gantry. Some Odyssey computers operate as stand alone workstations. A Prism XPVTSystem, Tomography, Computed, Emission, 90KPS System.
REASON
A broken gantry wire may prevent the contact sensors from stopping motion of the unit.
CODE
Serial Numbers: 101 to 763.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Highland Heights, OH, by letter dated October 8, 2001. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
653 devices installed.
DISTRIBUTION
Nationwide and Internationally.
