Z-0897-2013Class II

Ingenuity TF PET/CT. Diagnostic imaging system

Name: Z-0897-2013 Ingenuity TF PET/CT. Diagnostic imaging system
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2013-01-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-01-21 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Ingenuity TF PET/CT. Diagnostic imaging system on 2013-01-21. FDA classified it as Class II and gives the reason as "The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients". 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-0897-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-21
Posted: 2013-02-28
Terminated: 2013-07-19
Recalling firm: Philips North America LLC
Product: Ingenuity TF PET/CT. Diagnostic imaging system
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.
Root cause tag: software
FDA root cause: Software design
Action: Philips Medical Systems (Cleveland), Inc. sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated January 21, 2013 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact your local Philips representative or Philips Healthcare office for further information concerning this issue.
Quantity in commerce: 1 Unit
Distribution: Distributed only in Ohio.
Product codes and lots: Model # 882456, Serial # 2004. Units currently running Ingenuity TF PET/CT system software version 4.0.0.26635.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0897-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0897-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-28

Product code KPS

K052640Class IIGemini RaptorPhilips Medical Systems (Cleveland), Inc. / cleared 2005-10-07

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)