—#96728

Product

Precedence Imaging System; 16 Slice 5/8, 16 slice 3/8; Philips Medical Systems An imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K041218
Affected lot / code info: Catalog number 882350; Model numbers (5/8): 4535-602-50861, 2169-3001A; Serial numbers: KP05100002 KP05110003 3000006 3000003. Model numbers (3/8): 2169-3000A, 4535-602-50851. Serial numbers: 3000034 3000040 3000044 3000046 3000047 3000049 3000059 3000061 3000063 3000071 3000072 3000074 3000078 30006120020 30007060027 30007060029 KP05040006 KP05080007 KP0510008 KP06040012 KP06060014 KP06100016 3000032 3000054 3000085.

Why it was recalled

Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised.

Root cause (FDA determination)

Other

Action the firm took

Urgent - Medical Device Correction notifications were sent to all domestic consignees on December 28, 2010 via Federal Express. The letter identified the affected products, the reason for the recall, the hazard involved, and actions to be taken by the customer/user. Customers have been instructed to immediately stop using the system and contact a Philips service representative for an immediate inspection if one of the listed reasons apply. Customers were also instructed to follow the instructions in the system's Instructions For Use to avoid a collision or force on the detector. The firm's service will contact customers to arrange a time for Philips to conduct an inspection and to conduct the appropriate field safety correction. The letter should be placed in customers' Instructions For use. Notices to international consignees will be sent as soon as translation is complete. If customers need further information or support concerning this issue, they should contact their local Philips representative.

Recalling firm

Firm: Philips Medical Systems
Address: 3860 N 1st St, San Jose, California 95134-1702

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2010-12-28
Posted by FDA: 2011-03-04
Terminated: 2012-04-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96728. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.