FDA Recall Terminated

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: Z-1056-2012 · Initiated December 13, 2011

Recall

Recall Number: Z-1056-2012
Event Number: 61110
Firm: Philips Medical Systems (Cleveland) Inc
FEI Number: 1525965
Product Code: KPS
Status: Terminated
Root Cause: Software design
Initiated: December 13, 2011
Posted: February 17, 2012
Terminated: February 22, 2013
Address: 595 Miner Road, Cleveland, OH, 44143-2131

Description

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.

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.

Distribution

Nationwide Distribution -- OH and MD.

Quantity

two (2) units were distributed