Philips CombiDiagnost PCF X-ray System Software Recall
Philips is recalling 131 CombiDiagnost PCF X-ray systems due to a software error that locks the table and an incorrectly installed thermos switch.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, and the agency classification is Class II, which aligns with the 'High' severity criteria for theoretical or unreported harm risks.
Plain-English summary
Philips Medical Systems Gmbh, DMC is recalling 131 units of the CombiDiagnost PCF X-ray system, Software v. 1.0.5, Product Code 709030. The recall covers systems distributed worldwide, including in the United States and various international markets.
The recall is due to two defects: a software issue where using the Table Up/Down button may trigger Error 80, locking the table geometry and requiring service engineer intervention, and a production error where the thermos switch, designed to power down the unit during transformer overheating, was installed incorrectly. The source text does not report any injuries, illnesses, or deaths associated with these defects.
Healthcare facilities and users should contact Philips Medical Systems for instructions on how to resolve the software error and correct the thermos switch installation. Specific serial numbers for domestic units are listed in the recall documentation.
The recalled product
- Product
- CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
- Manufacturer
- Philips Medical Systems Gmbh, DMC
- Category
- Medical Device — X-ray System
- Affected units
- 131
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips Medical Systems Gmbh, DMC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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