Food, drugs, devices › Philips Medical Systems (Cleveland) Inc
Device recall: Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomograp
Philips Medical Systems (Cleveland) Inc (Cleveland, OH) initiated this device recall on 16 Aug 2013; FDA lists 1 product record under event 66205, 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 26 Mar 2014. 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
"Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a patient rescan were to require reinjection of PET radiopharmaceutical."
Distribution
"Worldwide Distribution - US (nationwide) including the states of NY, OH and Pa, and the countries of Australia, Austria, Egypt, France, Germany, India and Netherlands."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0067-2014 | Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces… | 13 | Class II | Terminated | 6 Nov 2013 |
Context
Other enforcement events for Philips Medical Systems (Cleveland) Inc
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: "Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a patient rescan were to require reinjection of PET radiopharmaceutical."
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: "Worldwide Distribution - US (nationwide) including the states of NY, OH and Pa, and the countries of Australia, Austria, Egypt, France, Germany, India and Netherlands."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 Mar 2014. "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.