Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Brand
Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany
Lot Codes / Batch Numbers
(domestic only) SN374 SN17081704 SN17121782 SN18011800 SN18081862 SN18061846 SN18111907
Products Sold
(domestic only) SN374 SN17081704 SN17121782 SN18011800 SN18081862 SN18061846 SN18111907
Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany is recalling CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, due to When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention o. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On December 19, 2019, the firm initiated mailing of the Medical Device Recall Letter to all affected customers. Customers were advised to use the system according to the Instructions for Use (IFU). In particular: Error 80 issue: The issue can be prevented if the operator avoids tilting the table by Table Up/Down joystick and instead uses the Table Tilt Left/Right joystick. If the issue occurs, the operator should remove the patient from the table and bring him/her to upright position so that the contrast agent does not enter the brain. SPDU issue: The user should pay attention to whether it smells of smoke in the room. If this is the case, immediately engage the system emergency stop button on the table or geometry control console, remove patient, stop using the system for further examinations and contact customer service. Philips plans to install a system software version upgrade and to perform an on-site check of the SPDU thermos contact at affected systems, which will eliminate these issues. A Philips Service Engineer will contact you when the Field Action Kit is available to be implemented. Should you need to communicate with Philips with regard to this program, please reference Field Change Order (FCO) 70900045 if you have a CombiDiagnost GCF system and FCO 70900048 if you have a CombiDiagnost PCF system. Technical Support Line: 1-800-722-9377.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026