Device product
Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
Z-1806-2020
Product summary
- Event
- Event 85472
- Status
- Terminated
- Classification
- Class II
- Quantity
- 346 units (5 US and 341 OUS)
- Official record key
device-enforcement:Z-1806-2020
Official wording
Reason: If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.
Code information: All serial numbers
Distribution pattern: 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.
Derived failure modes
-
Unknown
If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.