Recall Z-1329-2020— Philips Medical Systems Gmbh, DMC
Class II · Ongoing
Class II FDA medical device recall by Philips Medical Systems Gmbh, DMC, initiated 2019-12-19, terminated 2020-06-18. It names one FDA 510(k) clearance: K163210. 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..
- Recalling firm
- Philips Medical Systems Gmbh, DMC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-12-19
- Terminated
- 2020-06-18
- Firm location
- Hamburg, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.