Agency classClass IIOur severity:High FDA (Devices)·Z-0883-2013·Announced 2013-03-06

Philips GEMINI TF Big Bore PET/CT Systems Recalled for Software Error

Philips is recalling 37 GEMINI TF Big Bore PET/CT systems because a software error may cause generated Intensity Projection data to be flipped and incorrectly labeled.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software error that results in incorrectly labeled medical imaging data, which poses a risk of harm through potential misdiagnosis, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 37 units of the GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system. The recall is due to a software anomaly in the TumorLOC program. The affected systems are distributed worldwide, including in the United States and Canada.

The TumorLOC software has the capability to generate Intensity Projection data sets from respiratory gated data. Philips identified a circumstance where these generated datasets are 'flipped' and incorrectly labeled left-to-right when saved to disk. This error affects the accuracy of the data generated by the software.

The affected systems are identified by specific serial numbers listed in the recall documentation. Users of these systems should contact Philips Medical Systems for further instructions regarding the software issue.

The recalled product

Product: Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed…
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Diagnostic Imaging
Hazard: software-error
mis-labeling
Affected units: 37

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 (20)

9005
9006
9008
9009
9010
9011
9012
9013
9014
9016
9017
9018
9019
9020
9021
9022
9023
9201
9202
9203

Distribution

Distributed in 43 states:

Part of a larger recall action

This product is one of 4 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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