Recall Z-1029-2013— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1029-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-20

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2012-12-20, terminated 2013-06-18. It names one FDA 510(k) clearance: K052640. Product: Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.. Reason: Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland), Inc. is issuing a software update to address the issues..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2012-12-20
Terminated: 2013-06-18
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

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

Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

Reason for recall

Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland), Inc. is issuing a software update to address the issues.

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