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

FDA device recall Z-1056-2012 · posted 2012-02-17 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

KPS

Quantity affected

two (2) units were distributed

Distribution

Nationwide Distribution -- OH and MD.

Date initiated

2011-12-13

Date posted

2012-02-17

Date terminated

2013-02-22

Location

Cleveland, OH

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