Jan

2003

Philips Medical Systems Class II

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.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Philips Medical Systems Class II

Amy Sellers

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