Philips CombiDiagnost R90 X-Ray System Recalled for Electrical Safety Defect
Philips is recalling 10 CombiDiagnost R90 X-ray systems because a protective earthing wire was removed and non-standard spacers were used.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural electrical safety defect (removal of protective earthing wire), which meets the rubric criteria for a Severe rating.
Plain-English summary
Philips Electronics North America Corporation is recalling 10 units of the CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system. The recall was initiated because the green/yellow protective earthing (PE) wire on the tube adapter-plate was removed. Additionally, spacers with different thicknesses were used to position the pre-loc ring relative to the focal spot, deviating from the specified distance.
The affected devices were distributed in the United States, France, Germany, Luxembourg, and New Zealand. The CombiDiagnost R90 is a multi-functional general radiography and fluoroscopy system used for routine exams, including angiography and pediatric work, but excluding mammography.
Healthcare facilities should contact Philips to arrange for the inspection and correction of the electrical safety defect. The recall is classified as Class II by the FDA, indicating a reasonable probability that the defect could cause temporary or medically reversible health consequences.
The recalled product
- Product
- CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All CombiDiagnost R90 UDI 709030
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Philips Electronics North America Corporation
See all →- HighPhilips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors
FDA (Devices) · 2018-12-26
- ModeratePhilips IntelliVue MX40 Patient Monitor Speaker Volume Recall
FDA (Devices) · 2018-12-19
- HighPhilips Medical Monitor Ceiling Suspension Recall for Detachment Risk
FDA (Devices) · 2018-10-03
- HighPhilips Allura Xper FD2O Ceiling Monitor Suspension Recall
FDA (Devices) · 2018-10-03
- HighPhilips AlIura Xper F010 F Monitor Ceiling Suspension Recall
FDA (Devices) · 2018-10-03
Same hazard · electrical shock
See all →- HighFort Defiance Automated Field Steam Sterilizer Recalled for Electrical Grounding Defect
FDA (Devices) · 2026-08-26
- SevereJayco Recalls 2026 Seismic Fifth Wheel Toy Haulers Due to Fire Risk
NHTSA · 2026-07-02
- Severe
- HighLomi roll-on waxing kit power cords can overheat and short circuit
CPSC · 2026-06-25
- High