Philips BV Endura Mobile X-Ray system with the extended rotation option.
This recall has been terminated (originally issued September 22, 2010).
- Recall Initiated
- September 10, 2008
- Posted
- September 22, 2010
- Terminated
- January 7, 2011
- Recall Number
- Z-2464-2010
- Quantity
- 71 units
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
The C-arm rotation brake does not always function properly, and may not hold the C-arm position if the C-arm is not positioned in its maximum rotation and if it is accidentally bumped by medical staff or patients. Unwanted C-arm movement may cause the C-arm to collide with a patient. The brakes function properly if the C-arm is rotated to its maximum positions.
Distribution
Nationwide Distribution: Throughout the US.
Lot / Code Info
Devices are identified with Site Numbers: 548598, 550838, 551589, 551695, 552444, 552467, 552468, 552669, 553171, 553860, 553917, 553976, 553989, 554350, 554497, 555001, 555021, 555243, 555395, 555463, 555517, 556135, 556171, 556531, 556587, 556608, 556612, 556678, 556862, 556977, 556979, 557037, 557063, 557590, 558233, 558237, 558613, 558975, 559070, 559663, 559665, 41416327, 41443860, 41445126, 41445430, 41445445, 41445552, 41566246, 41585083, 41658558, 41765654, 41796621, 41905206, 41938039, 41955473, 42045315, 42162893, 42291865, 42326711, 42373518, 42382482, 42394051, 42608281, 42639034, 42824768, 42861875, 42869100, 42869163, 42880805, 42966787, and 42975222.
Root Cause
Other
Action Taken
Philips Medical Systems issued an Urgent Product Correction letter dated September 30, 2008 to consignees. The letter identified the affected device, what the problem is and under what circumstances it can occur, and the actions that should be taken by the customer or user in order to prevent risks for patients or users. Philips will contacdt customers to implement Field Corrective Action (FCO) #71800026), which describes a mechanical brake modification which will be installed by Philips. Until the Field Corrective Action has been completed, users should ensure that the C-arm is placed in the maximum extended position, or ensure that the C-arm is not touched during critical procedures if the C-arm is not in a maximum position. The Philips Call Center can be contacted at 800-722-9377