Philips DuraDiagnost X-Ray System Recalled for Installation Defects
Philips Medical Systems is recalling 71 DuraDiagnost X-Ray systems worldwide due to improper installation risks that could cause equipment to fall or float.
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 involves a structural defect in a medical device where the equipment may fall or float, which aligns with the rubric criterion for 'structural vehicle defect' or significant injury/property-damage reports, warranting a Severe rating.
Plain-English summary
Philips Medical Systems, Inc. is recalling 71 units of the Philips DuraDiagnost X-Ray system, specifically models 712210 and 712211. The recall covers units distributed worldwide, including locations in Argentina, Australia, Burkina-Faso, Chile, China, Colombia, Ecuador, France, Germany, Hungary, Indonesia, Iraq, Kuwait, Libya, Macedonia, Malaysia, Mayotte, Poland, Saudi Arabia, Slovenia, Spain, Switzerland, Turkey, the United Kingdom, and Uzbekistan.
The recall is being issued because improper installation of the tube arm and wall stand may cause the equipment to fall down. Additionally, improper installation of the table may cause it to float. These installation defects present a physical hazard to the equipment and potentially to personnel in the vicinity.
Healthcare facilities and consumers who possess these specific serial numbers should contact Philips Medical Systems for instructions on how to resolve the installation issues. The recall number for this action is Z-1251-2015.
The recalled product
- Product
- Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 71
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Philips Medical Systems, Inc.
See all →- ModeratePhilips Medical Systems Recalls Foot Switches for Bent Pedal Defect
FDA (Devices) · 2016-04-06
- ModeratePhilips MultiDiagnost Eleva Foot Switches Recalled for Bent Pedal Defect
FDA (Devices) · 2016-04-06
- SeverePhilips IntelliVue Information Center iX Software Recall for Alarm Failure
FDA (Devices) · 2015-12-16
- HighPhilips INTEGRIS Cardio System Ceiling Suspension Recall
FDA (Devices) · 2015-12-09
- HighPhilips Allura BiPlane Ceiling Suspension System Recall for Fall Risk
FDA (Devices) · 2015-12-09
Same hazard · falling equipment
See all →- HighMultitom Rax X-Ray Systems Support Arm May Lower Unexpectedly
FDA (Devices) · 2024-08-14
- HighMaquet Prismalix OR Light Systems recalled due to fall hazard
FDA (Devices) · 2024-01-24
- HighMedical Ultrasound Cart Recall: Tilt Mechanism Failure Can Cause Equipment to Fall
FDA (Devices) · 2023-10-11
- HighOEC 9900 Systems Image Intensifier Detachment and Fall Risk
FDA (Devices) · 2023-08-09
- HighX-ray imaging system ceiling suspension may descend without adequate maintenance
FDA (Devices) · 2023-04-19