Z-1806-2020 Class II Terminated
FDA device recall Z-1806-2020 was initiated by Philips North America, LLC on April 7, 2020 and is designated Class II. Reason for recall: If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury. The recall status is terminated (terminated April 28, 2023). Affected quantity: 346 units (5 US and 341 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- April 7, 2020
- Termination Date
- April 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 346 units (5 US and 341 OUS)
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.
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.
Code Information
All serial numbers