Z-1056-2012

TruFlight Select PET/CT System equipped with software version 3.5.3.10, Model #459800111661. A diagnostic...

Name: Z-1056-2012 TruFlight Select PET/CT System equipped with software version 3.5.3.10, Model #459800111661. A diagnostic...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2011-12-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-12-13 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of 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... on 2011-12-13. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1056-2012
Status: Terminated
Initiated: 2011-12-13
Posted: 2012-02-17
Terminated: 2013-02-22
Recalling firm: Philips North America LLC
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.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: 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 tag: software
FDA 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 in commerce: two (2) units were distributed
Distribution: Nationwide Distribution -- OH and MD.
Product codes and lots: Software version 3.5.3.10, Serial Numbers: 17002 and 17003.

Product code KPS

K052640Class IIGemini RaptorPhilips Medical Systems (Cleveland), Inc. / cleared 2005-10-07

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)