medical Class II Updated 2020-02-26

Philips Medical Systems Gmbh, DMC recalls CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 -

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: (domestic only) SN374 SN17081704 SN17121782 SN18011800 SN18081862 SN18061846 SN18111907
View official government recall

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