FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: TruFlight Select PET/CT System equipped with software version 3.5.3.10, Model #459800111661. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
- Recall number
- Z-1056-2012
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- TruFlight Select PET/CT System equipped with software version 3.5.3.10, Model #459800111661. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
- Status
- Terminated
- Initiated
- 2011-12-13
- Posted
- 2012-02-17
- Terminated
- 2013-02-22
- Reason
- A number of non-conformances have been noted in the TruFlight Select PET/CT System. A number of these non-conformances have been corrected to improve the overall quality and functionality of the suspect system units.
- Root cause
- Software design
- Action
- Philips sent an 'URGENT - Medical Device Correction TruFlight Select PET/CT Serial Numbers: 17002, 17003 letters. The letter was dated December 13, 2011. The letter describes the affected product, the nature of the problem along with the circumstances under which this problem can occur; the hazard involved and actions to be taken by the customer/user. In this case, the customers (operator/users) are provided with separate recommended actions. The letter goes on to notify the customers that a Philips representative will be visiting each customer site and installing a software update (3.5.3) in order to address several of the non-conformance issues through a Field Change Order. For further information or support concerning this issue contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center at (1-800-722-9377, Customers in all other countries are advised to dial their local Philips Healthcare office.
- Quantity
- two (2) units were distributed
- Distribution
- Nationwide Distribution -- OH and MD.
- Lot, serial or model codes
- Software version 3.5.3.10, Serial Numbers: 17002 and 17003.
- 510(k) numbers
- ["K052640"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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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