Philips TraumaDiagnost X-Ray System Recalled Due to Potential Shaft Failure
Philips North America is recalling 346 TraumaDiagnost X-Ray systems because a shaft may break due to material fatigue, causing the arm to fall and potentially injure patients or staff.
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 is classified as FDA Class II and involves a structural defect (shaft breakage) that can cause the arm to fall, posing a risk of significant injury.
Plain-English summary
Philips North America, LLC is recalling 346 units of the Philips TraumaDiagnost Stationary X-Ray System (Bucky System), Model 720013. The recall involves 5 units in the United States and 341 units outside the US. The affected systems are used for general radiography.
The recall is being issued because the shaft of the trauma arm may break due to material fatigue. If the shaft breaks, the trauma arm can fall down, which may result in injury to patients or medical staff.
The affected units were distributed worldwide, including in the US states of California, Maine, Rhode Island, Texas, and Wisconsin, as well as in Canada, Australia, Austria, France, Germany, Greece, Hungary, Ireland, the Netherlands, Portugal, Slovenia, and the United Kingdom. All serial numbers are affected. Users of these systems should contact Philips North America for instructions on how to address the defect.
The recalled product
- Product
- Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
- Manufacturer
- Philips North America, LLC
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 serial numbers
Distribution
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