Recall Z-0823-2019— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-0823-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-19

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2018-12-19, terminated 2021-08-03. It names one FDA 510(k) clearance: K172406. Product: Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging).. Reason: A software update is being issued to correct multiple issues identified in the previous software version..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2018-12-19
Terminated: 2021-08-03
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K172406 — Ingenuity TFPhilips Medical Systems (Cleveland), Inc.·cleared 2017-10-06

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 (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging).

Reason for recall

A software update is being issued to correct multiple issues identified in the previous software version.

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