Philips CombiDiagnost GCF X-ray System Software Recall
Philips is recalling 116 CombiDiagnost GCF X-ray systems due to a software error that locks the table and an incorrectly installed thermos switch.
What this means for you
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 medical device with a functional defect that requires service intervention and a safety switch installed incorrectly, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Philips Medical Systems Gmbh is recalling 116 units of the CombiDiagnost GCF X-ray system, Software v. 1.0.5, Product Code 709030. The recall affects systems distributed worldwide, including in the United States and numerous international locations.
The recall is due to two specific defects. First, using the Table Up/Down button may trigger Error 80, which locks the table geometry in a specific state and requires intervention by a service engineer to resolve. Second, the thermos switch, which is designed to power down the unit if the transformer overheats, was installed incorrectly during production.
Healthcare facilities and users of these specific X-ray systems should contact Philips Medical Systems for instructions on how to resolve these issues. The source text does not report any injuries or illnesses associated with this recall.
The recalled product
- Product
- CombiDiagnost GCF, 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
- 116
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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