ModerateClass IITerminated

FDA Devices recall · Reported August 29, 2012

Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH. The device is a 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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on August 29, 2012. Severity: Moderate. Recall number: Z-2239-2012.

Q: Where was the recalled product distributed?

Distribution: Nationwide Distribution-including the states of CO, FL, MD, MN, NE and PA..

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.

Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a hole through the casing on one of the batteries. Supplier of the UPS, Chloride/Em…

Recall #: Z-2239-2012
Affected scope: 7 units
Initiated: August 8, 2012

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

Verify with FDA Devices →

View my saved recalls

Philips Medical Systems (Cleveland) Inc recalled Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GE… - a moderate-severity action.

Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GE… was recalled by Philips Medical Systems (Cleveland) Inc in August 29, 2012. Reason: Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a hole throug…. Check the official notice for the remedy. Verify recall #Z-2239-2012 with the FDA Devices before acting.

The recall

Philips Medical Systems (Cleveland) Inc issued this moderate-severity FDA Devices recall-Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a hole throug….

Moderate
severity level: 7 units
affected scope: Class II
classification: August 29, 2012
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2239-2012 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

Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH. The device is a 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 organ 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 with regional cerebral activity from PET images.

Reason for recall

Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a hole through the casing on one of the batteries. Supplier of the UPS, Chloride/Emerson, determined the batteries, housed within the UPS battery cabinet, entered thermal runaway causing the battery to overheat.

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-2239-2012
Date reported	August 29, 2012
Date initiated	August 8, 2012
Recalling firm	Philips Medical Systems (Cleveland) Inc
Firm location	Cleveland, OH
Affected scope	7 units
Distribution	Nationwide Distribution-including the states of CO, FL, MD, MN, NE and PA.

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

Scale of Impact

7 units 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-2239-2012) 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? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 29, 2012. Severity: Moderate. Recall number: Z-2239-2012.

Where was the recalled product distributed? ▼

Distribution: Nationwide Distribution-including the states of CO, FL, MD, MN, NE and PA..

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

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Cooper Lighting Recalls Shower Light Trim… 2012-08-29 Summer Infant Recalls to Repair Baby Bath… 2012-08-29 Custom Access Tray, Sterile, contains Sod… 2012-08-29 CMS-8934 Custom Phlebectomy Tray, Sterile… 2012-08-29

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Alaris Pump Module Model 8100 (formerly M… 2012-08-29 syngo Dynamics Version 9.5 2012-08-29 Altrx" Altralinked" Polyethylene liners … 2012-08-29 GEHC OEC 8800 Mobile Fluoroscopic X-ray S… 2012-08-29

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported August 29, 2012. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026