FDA Medical Device Recalls (openFDA)
Philips Medical Systems: 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.
- Recall number
- Z-1549-2011
- Recalling firm
- Philips Medical Systems
- 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.
- Status
- Terminated
- Initiated
- 2010-12-28
- Posted
- 2011-03-04
- Terminated
- 2012-04-02
- Reason
- Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised.
- 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
- 540 units, all varieties
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K041218"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 1525965
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28