The Recall Desk
SevereFDA (Devices)·Z-1806-2020·Announced 2020-05-06

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.

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 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.

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

Distributed nationwide across the United States.

The notice also names 5 states specifically: