ModerateClass IITerminated

FDA Devices recall · Reported November 6, 2013

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 images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other Oran imaging). Attenuation

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on November 6, 2013. Severity: Moderate. Recall number: Z-0067-2014.

Q: Where was the recalled product distributed?

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..

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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.

Recall #: Z-0067-2014
Affected scope: 13
Initiated: August 16, 2013

Compiled from official public sources by the publisher. · Updated September 2026

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Philips Medical Systems (Cleveland) Inc recalled Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that c… - a moderate-severity action.

Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that c… was recalled by Philips Medical Systems (Cleveland) Inc in November 6, 2013. Reason: Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a p…. Check the official notice for the remedy. Verify recall #Z-0067-2014 with the FDA Devices before acting.

The recall

Philips Medical Systems (Cleveland) Inc issued this moderate-severity FDA Devices recall-Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a p….

Moderate
severity level: 13 units
affected scope: Class II
classification: November 6, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0067-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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 images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other Oran imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders The detection, localization, and staging of tumors and diagnosing cancer patients. Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for quantification of cardiology images and data sets including but not limited to myocardial perfusion for the display of wall motion and quantification ventricular or left-function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated.

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0067-2014
Date reported	November 6, 2013
Date initiated	August 16, 2013
Recalling firm	Philips Medical Systems (Cleveland) Inc
Firm location	Cleveland, OH
Affected scope	13
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.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

13 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0067-2014) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

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.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on November 6, 2013. Severity: Moderate. Recall number: Z-0067-2014.

Where was the recalled product distributed? ▼

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..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

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This recall: FDA Devices, reported November 6, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026