Z-2491-2015Class II

Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems

Name: Z-2491-2015 Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2015-07-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-07-23 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems on 2015-07-23. FDA classified it as Class II and gives the reason as "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...". 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-2491-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-23
Posted: 2015-08-31
Terminated: 2018-06-26
Recalling firm: Philips North America LLC
Product: Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Product code: OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
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.
Root cause tag: software
FDA root cause: Software design
Action: On July 23, 2015 the firm sent Field Safety Notices to their customers.
Quantity in commerce: 11
Distribution: Product was shipped to the following states: NY, OH & TX. Product was also shipped to the following countries: Finland, Germany, Hong Kong, Japan, Netherlands, South Korea, Spain & Switzerland.
Product codes and lots: M/N 882380; S/N: 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-2491-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2491-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31

Product code OUO

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)