Recall Z-0932-2014— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-0932-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-04

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2013-12-04, terminated 2016-02-02. It names 2 FDA 510(k) clearances: K081135, K052640. Product: Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476). Reason: The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2013-12-04
Terminated: 2016-02-02
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

2 on FDA's record

K081135 — GEMINI CONDORPhilips Medical Systems (Cleveland), Inc.·cleared 2008-04-29
K052640 — GEMINI RAPTORPhilips Medical Systems (Cleveland), Inc.·cleared 2005-10-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)

Reason for recall

The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study.

Data sourced from openFDA. This site is unofficial and independent of the FDA.