Z-2198-2015Class II

GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic...

Name: Z-2198-2015 GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2015-07-01
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-07-01 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron... on 2015-07-01. FDA classified it as Class II and gives the reason as "Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue". 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-2198-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-01
Posted: 2015-07-22
Terminated: 2018-06-26
Recalling firm: Philips North America LLC
Product: GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
Root cause tag: software
FDA root cause: Software design
Action: On 7/6/2015 the firm sent Field Safety Notices to their customers.
Quantity in commerce: 2 Units
Distribution: Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.
Product codes and lots: Model #882473 GEMINI TF Base (453567441711); Serial Number: 7111 & 7150.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2198-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2193-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-22
Z-2194-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-22
Z-2195-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-22
Z-2196-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-22
Z-2197-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-22
Z-2198-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-22
Z-2199-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-22

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