Recall Z-1682-2015— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1682-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-11

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2015-03-11, terminated 2018-06-26. It names one FDA 510(k) clearance: K103483. Product: Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).. Reason: It was noticed that the spectroscopy voxel map did not align with the anatomical images of the phantom. This resulted in incorrect orientation of the Chemical Shift Imaging (CSI) data..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2015-03-11
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 Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).

Reason for recall

It was noticed that the spectroscopy voxel map did not align with the anatomical images of the phantom. This resulted in incorrect orientation of the Chemical Shift Imaging (CSI) data.

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