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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
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