Z-1682-2015Class II

Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical...

Name: Z-1682-2015 Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2015-03-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-03-11 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. The device is a diagnostic imaging... on 2015-03-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1682-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-11
Posted: 2015-05-28
Terminated: 2018-06-26
Recalling firm: Philips North America LLC
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).
Product code: KPS System, Tomography, Computed, Emission
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.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: On 3/11/2015 the firm sent Urgent - Medical Device Correction letters to their customers. The letters identified the affected device, explained the reason for the recall, how to identify affected product, advice on actions to be taken by customer/user, and any actions planned by the firm. Customers were advised to use software provided by Philips to view spectroscopy images; and, not to export and view images using third party software. The firm stated that it will be issuing a software update. If further information or support concerning the issue is needed, customers are asked to contact their local Philips representative or local Philips Healthcare office.
Quantity in commerce: 10 units
Distribution: Worldwide Distribution -- US, including the states of NY, OH, & TX; and, the countries of Finland, Germany, Japan, Netherlands, South Korea, Spain, & Switzerland.
Product codes and lots: Serial #'s: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1682-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1682-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-28

Product code KPS

K103483Class IIIngenuity Tf Pet/mrPhilips Healthcare (Cleveland) / cleared 2011-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)