Z-1549-2011

Precedence Imaging System; 16 Slice 5/8, 16 slice 3/8; Philips Medical Systems An imaging system combining...

Name: Z-1549-2011 Precedence Imaging System; 16 Slice 5/8, 16 slice 3/8; Philips Medical Systems An imaging system combining...
Creator: Philips Medical Systems
Published: 2010-12-28
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-12-28 / Terminated

FDA source

Philips Medical Systems began a recall of 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... on 2010-12-28. The reason FDA records is "Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1549-2011
Status: Terminated
Initiated: 2010-12-28
Posted: 2011-03-04
Terminated: 2012-04-02
Recalling firm: Philips North America LLC
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.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised.
FDA root cause: Other
Action: 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.
Quantity in commerce: 540 units, all varieties
Distribution: Worldwide Distribution
Product codes and lots: 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.

Product code JAK

K041218Class IIGriffin Spect/ct Imaging SystemAdac Laboratories / cleared 2004-05-24

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)