FDA-Device2020-05-06Class II
Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
Philips North America, LLC
Hazard
If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.
Sold states
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.
Affected count
346 units (5 US and 341 OUS)
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1806-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief