Company: Philips Medical Systems Gmbh, DMC
Date of Enforcement Report: 2/26/2020
Class II

PRODUCT

CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 – Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.

• Recall Number: Z-1328-2020

REASON

When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production.

RECALLING FIRM/MANUFACTURER

Philips Medical Systems Gmbh, DMC on 12/19/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

116

DISTRIBUTION

US Nationwide and Worldwide