—#74614

Product

Philips BV Endura Mobile X-Ray system with the extended rotation option.

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K010435
Affected 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.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Nationwide Distribution: Throughout the US.

Timeline

Recall initiated: 2008-09-10
Posted by FDA: 2010-09-22
Terminated: 2011-01-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74614. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.