FDA Device recall Z-1328-2020
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose
- FDA Device
- Class II
- ongoing
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class II recall of CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose by Philips Medical Systems Dmc, citing 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. Additio….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1328-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-12-19 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips Medical Systems Dmc |
| Distribution | US |
Product
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
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.
Identifiers
| code_info | (domestic only) SN18061848 SN17071689 SN18051832 SN190251 SN17111759 SN17111752 SN18011793 10000020 SN17121783…(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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1328-2020%22
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