FDA Device recall Z-1329-2020
CombiDiagnost PCF, 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 PCF, 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-1329-2020 |
| 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 PCF, 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) SN374 SN17081704 SN17121782 SN18011800 SN18081862 SN18061846 SN18111907 |
|---|
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-1329-2020%22
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