Agency classClass IIOur severity:Severe FDA (Devices)·Z-2239-2012·Announced 2012-08-29

Philips PET/CT Systems Recalled Due to UPS Battery Thermal Runaway

Philips is recalling seven PET/CT systems because a UPS battery cabinet experienced thermal runaway, causing a battery to overheat and burn through the casing.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a thermal runaway event that caused a battery to overheat and burn through its casing, representing a significant fire hazard and property damage risk consistent with the 'Severe' rubric criteria.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling seven units of Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems, specifically the GEMINI TF 16, GEMINI GXL 16, and GEMINI TF Big Bore models. The recall involves specific serial numbers for these diagnostic imaging systems, which are used for evaluating and diagnosing various medical conditions.

The recall was initiated after Philips identified an issue with the Uninterruptible Power Supply (UPS) battery cabinet associated with the devices. The supplier of the UPS, Chloride/Emerson, determined that the batteries housed within the cabinet entered thermal runaway, causing the batteries to overheat. This overheating resulted in a battery burning a hole through the casing of the UPS battery cabinet.

The affected units were distributed nationwide, including in the states of Colorado, Florida, Maryland, Minnesota, Nebraska, and Pennsylvania. The source text does not specify further actions for consumers or healthcare facilities beyond the identification of the defect.

The recalled product

Product: 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…
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Diagnostic Imaging
Hazard: fire
thermal-runaway
Affected units: 7

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

GEMINI TF 16 System serial numbers: 7194
7186
7235
9201

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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