Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.
This recall has been terminated (originally issued July 22, 2015).
- Recall Initiated
- July 22, 2015
- Terminated
- October 14, 2020
- Recall Number
- Z-0766-2016
- Quantity
- 399 distributed, 262 are subject to this event
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
If arm is not fastened securely it could fall down.
Distribution
Distributed in the states of NY, WI, MA, AL, FL, GA, RI, CA, KS, and TX, and the countries of Canada, Australia, Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, New Zealand, Portugal, South Africa, Spain, and Switzerland.
Lot / Code Info
All TraumaDiagnost products that were delivered before the week of July 2, 2007.
Root Cause
Nonconforming Material/Component
Action Taken
Consignees were notified of the recall via letter sent certified return receipt on 7/22/2015. The letter informs customers that the Instruction for Use (IFU) requires the operator not to use the system and call for service, if a mechanical defect or malfunction is suspected. In this case, it is recommended not to position the Ceiling suspension with the Trauma arm directly above a patient as long as this Field Change Order is not yet installed. Philips plans to repair the affected systems. A Philips Service Engineer will contact customers as soon as the Field Action Kit is ready to be implemented. For questions, contact your local representative or use the Technical Support Line at 1-800-722-9377. When communicating with Philips regarding this issue, please reference Field Change Order 72000014.