PlainRecalls
FDA Devices Moderate Class II Terminated

Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.

Reported: May 6, 2020 Initiated: April 7, 2020 #Z-1806-2020

Product Description

Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.

Reason for Recall

If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.

Details

Units Affected
346 units (5 US and 341 OUS)
Distribution
Worldwide distribution - US Nationwide distribution including the states of CA, ME, RI, TX, WI and the countries of Canada, Australia, Austria, France, Germany, Greece, Hungary, Ireland, Netherlands, Portugal, Slovenia, United Kingdom.
Location
Andover, MA

Frequently Asked Questions

What product was recalled?
Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.. Recalled by Philips North America, LLC. Units affected: 346 units (5 US and 341 OUS).
Why was this product recalled?
If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 6, 2020. Severity: Moderate. Recall number: Z-1806-2020.