Agency classClass IIOur severity:Severe FDA (Devices)·Z-2195-2015·Announced 2015-07-29

Philips Recalls GEMINI TF 16 Slice CT/PET Systems Due to Software Defects

Philips is recalling 13 GEMINI TF 16 Slice CT/PET systems worldwide due to four software defects in the Tumor LOC application that may affect treatment accuracy.

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 is classified as FDA Class II and involves a medical device defect that may result in the irradiation of healthy tissue or the non-irradiation of diseased tissue, which constitutes a significant injury risk.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 13 units of the GEMINI TF 16 Slice CT/PET System. The recall covers systems distributed worldwide, including the United States, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela, and Vietnam.

The recall was initiated because Philips identified four software defects in the Tumor LOC software application. These defects may potentially result in the irradiation of healthy tissue or the non-irradiation of diseased tissue. The affected units are identified by Model #882470 and specific serial numbers listed in the agency record.

Healthcare facilities and consumers with these specific systems should contact Philips Medical Systems for instructions on how to resolve the software defects. The recall is classified as Class II by the FDA.

The recalled product

Product: GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Imaging Systems
Hazard: software-defect
radiation-exposure
treatment-error
Affected units: 13

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 (13)

Model #882470 GEMINI TF 16 Slice (453567983931)
Serial Number: 7052
7060
7093
7096
7121
7123
7128
7129
7185
7187
7220
7226 & 7570.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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