Z-2463-2010

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

Name: Z-2463-2010 Philips BV Pulsera Mobile X-Ray system with the extended rotation option
Creator: Philips Medical Systems North America Co. Phillips
Published: 2008-09-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-09-10 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Philips BV Pulsera Mobile X-Ray system with the extended rotation option on 2008-09-10. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2463-2010
Status: Terminated
Initiated: 2008-09-10
Posted: 2010-09-22
Terminated: 2011-01-07
Recalling firm: Philips North America LLC
Product: Philips BV Pulsera Mobile X-Ray system with the extended rotation option.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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.
FDA root cause: Other
Action: 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
Quantity in commerce: 1349 units
Distribution: Nationwide Distribution: Throughout the US.
Product codes and lots: Devices are identified with Site Numbers: 505029, 506745, 522087, 533824, 536622, 541547, 541556, 541557, 541558, 542423, 542426, 542427, 542584, 542684, 542769, 542854, 543059, 543219, 543220, 543222, 543458, 543459, 543460, 543461, 543462, 543463, 543464, 543465, 543862, 543947, 544191, 544396, 544411, 544456, 544457, 544458, 544459, 544460, 544461, 544462, 544463, 544464, 544465, 544466, 544467, 544469, 544470, 544471, 544473, 544474, 544475, 544476, 544533, 544562, 544622, 544972, 544984, 545085, 545102, 545103, 545139, 545140, 545284, 545397, 545492, 545631, 545751, 545822, 545922, 545924, 545961, 545996, 546086, 546145, 546461, 546508, 546516, 546531, 546579, 546680, 546687, 546786, 546788, 546851, 546999, 547000, 547082, 547169, 547171, 547172, 547221, 547284, 547288, 547299, 547375, 547602, 547603, 547643, 547656, 547684, 547710, 547746, 547790, 547791, 547805, 547839, 547975, 548004, 548104, 548308, 548354, 548366, 548385, 548397, 548398, 548569, 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Product code JAA

K010435Class IIPhilips Bv Pulsera/enduraPhilips Medical Systems, Inc. / cleared 2001-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)