Device recall: GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic…

Class II FDA enforcement event 71699. Recall start date: 1 Jul 2015. Status in the FDA record: Terminated. Termination date: 26 Jun 2018.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Philips Medical Systems (Cleveland) Inc started this device recall on 1 Jul 2015. The firm address in the FDA record is in Cleveland, OH. FDA put the recall in Class II. FDA event 71699 has 7 product records. The first FDA enforcement report date is 29 Jul 2015. The record gives the status Terminated, with the termination date 26 Jun 2018.

FDA enforcement report The 7 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa,…

Recalling firm

Philips Medical Systems (Cleveland) Inc, Cleveland, OH.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

7 product records in the event.

FDA event 71699: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2193-2015	GEMINI GXL 16 Slice 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.	2 units	Class II	Terminated	29 Jul 2015
Z-2194-2015	GEMINI LXL 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.	2 units	Class II	Terminated	29 Jul 2015
Z-2195-2015	GEMINI TF 16 Slice 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.	13 Units	Class II	Terminated	29 Jul 2015
Z-2196-2015	GEMINI TF 64 Slice 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.	22 Units	Class II	Terminated	29 Jul 2015
Z-2197-2015	GEMINI TF Ready 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.	1 unit	Class II	Terminated	29 Jul 2015
Z-2198-2015	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.	2 Units	Class II	Terminated	29 Jul 2015
Z-2199-2015	GEMINI TF Big Bore 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.	44 Units	Class II	Terminated	29 Jul 2015

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2015: 1,153
Share of these events in Class II: 91%
Product records in this event: 7Median of the firm: 1
Events of the firm on the register: 129

Other events of the firm

Other FDA enforcement events of Philips Medical Systems (Cleveland) Inc
Initiated	Product (first record)	Type	Class	Records
5 Aug 2025	Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)0088483	Device	Class II	1
17 Jul 2025	Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software	Device	Class II	1
30 Aug 2022	Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.	Device	Class II	1
19 Sep 2019	Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and posit	Device	Class I	5
24 Jun 2019	Ingenuity CT, Model # 728326, computed tomography x-ray system	Device	Class II	9
10 Jun 2019	BrightView SPECT, Model Number 882480	Device	Class II	3
3 Jun 2019	Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) sys	Device	Class II	1
19 Dec 2018	Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Em	Device	Class II	1
18 Oct 2018	Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images	Device	Class II	6
4 Sep 2018	Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnos	Device	Class II	1

Philips Medical Systems (Cleveland) Inc: all 129 events

Official channels

FDA enforcement report Z-2193-2015The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 71699. https://recallregister.com/fda/ii/71699/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa,…
What quantity of product is in FDA event 71699?: The event has 7 product records. The first record gives this quantity: 2 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2015 have the same class?: 91% of the 1,153 device events that started in 2015 are in Class II.