Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0882-2013·Announced 2013-03-06

Philips GEMINI PET/CT Systems Recalled for Software Data Flipping Error

Philips is recalling 30 GEMINI PET/CT systems because a software error causes Intensity Projection data to be flipped and mislabeled left-to-right.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a software data integrity error (flipped/mislabeled data) rather than a direct physical injury or acute health threat, fitting the criteria for a moderate severity recall involving potential adverse health consequences through misdiagnosis or data error.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 30 units of GEMINI LXL, GEMINI TF 16, and GEMINI TF 64 Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems. The recall involves specific serial numbers for these diagnostic imaging systems used in fixed or mobile installations.

The recall is due to a software anomaly in the TumorLOC program. The software can generate Intensity Projection data sets from respiratory gated data, but a circumstance was identified where these generated datasets are 'flipped' and incorrectly labeled left-to-right when saved to disk. This error affects the accuracy of the saved data.

The affected systems were distributed worldwide, including in the United States and Canada. Users of these specific systems should contact Philips Medical Systems for further instructions regarding the software issue.

The recalled product

Product: Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations…
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Diagnostic Imaging
Hazard: software-error
data-integrity
Affected units: 30

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)

Serial Numbers: 14702 and 14707
GEMINI TF 16 Model #882470
Serial Numbers: 7129
7121
7123
7128
7096
7133
7185
7187
7226
and 7220
GEMINI TF 16
Model #882473
Serial Numbers: 7150
and and 7237
GEMINI TF 64
Model #882471
Serial Numbers: 7103
7126

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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