Recall Z-0897-2013— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-0897-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-21

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2013-01-21, terminated 2013-07-19. It names one FDA 510(k) clearance: K052640. Product: Ingenuity TF PET/CT. Diagnostic imaging system. Reason: The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2013-01-21
Terminated: 2013-07-19
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

Reason for recall

The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.

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