Food, drugs, devices › Philips Medical Systems (Cleveland) Inc

Device recall: Ingenuity TF PET/CT. Diagnostic imaging system

FDA enforcement event 64403 · Class II · initiated 21 Jan 2013 · status Terminated · terminated 19 Jul 2013

DeviceVoluntary: Firm initiated1 product recordCleveland, OH

Philips Medical Systems (Cleveland) Inc (Cleveland, OH) initiated this device recall on 21 Jan 2013; FDA lists 1 product record under event 64403, classified Class II.

FDA defines Class II as 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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 19 Jul 2013. Initiation: voluntary: firm initiated. Philips Medical Systems (Cleveland) Inc has 129 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

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

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."

Distribution

"Distributed only in Ohio."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0897-2013	Ingenuity TF PET/CT. Diagnostic imaging system	1 Unit	Class II	Terminated	6 Mar 2013

Context

90%of 2013 device events are Class II1,236 events that year

1product record in this eventfirm median: 1

129events on this register for the firm

Other enforcement events for 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

All 129 events for Philips Medical Systems (Cleveland) Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Distributed only in Ohio."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 19 Jul 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.