Recall Z-2491-2015— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-2491-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-23

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2015-07-23, terminated 2018-06-26. It names one FDA 510(k) clearance: K103483. Product: Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems. Reason: Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2015-07-23
Terminated: 2018-06-26
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K103483 — INGENUITY TF PET/MRPhilips Healthcare (Cleveland)·cleared 2011-11-23

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/MR, Diagnostic Imaging System , Philips Medical Systems

Reason for recall

Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems.

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