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

FDA device recall Z-2463-2010 · posted 2010-09-22 · Terminated

Recall details

Recalling firm

Philips Medical Systems North America Co. Phillips

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.

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

Root cause

Other

Status

Terminated

Product code

JAA

Quantity affected

1349 units

Distribution

Nationwide Distribution: Throughout the US.

Date initiated

2008-09-10

Date posted

2010-09-22

Date terminated

2011-01-07

Location

Bothell, WA

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