Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
This recall has been terminated (originally issued April 7, 2020).
- Company
- Philips North America, Llc
- Recall Initiated
- April 7, 2020
- Terminated
- April 28, 2023
- Recall Number
- Z-1806-2020
- Quantity
- 346 units (5 US and 341 OUS)
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.
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.
Lot / Code Info
All serial numbers
Root Cause
Device Design
Action Taken
Philips issued Urgent Field Safety Notice (FCO72000015) sent 4/09/20 via certified mail states reason for recall health risk, action to take: The IfU (Instruction for Use) require the operator to not use the system and call for service, if a mechanical defect or malfunction is suspected. As soon as a deformation is determined, the system may no longer be used and call the service engineer. Should you feel uncertain regarding these instructions, please contact Philips. If you would like any further information or support concerning this issue, please contact your local Philips representative.