medical Class II Updated 2020-02-26

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

Recalled Product

CombiDiagnost GCF, 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) SN18061848 SN17071689 SN18051832 SN190251 SN17111759 SN17111752 SN18011793 10000020 SN17121783 SN17121785 SN18021816 SN18101890 SN19031950 SN17071688 SN18101903 SN17071683 SN17101722 SN17101729 SN17111758 SN17111763 SN17031622 SN17071692 SN17041642 SN18101886 SN18011794 SN19021934 SN19021943 SN17111770 SN18011802 SN19021942 SN17121779 SN17031618 SN17101733 SN17021613 SN17021613
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