Agency classClass IIOur severity:High FDA (Devices)·Z-1134-2023·Announced 2023-02-22

SIEMENS Biograph Horizon 3R Mobile PET gantry locking mechanism defect

Siemens is recalling the Biograph Horizon 3R Mobile PET/CT system due to a potential failure of the locking mechanism that secures the PET gantry in its scanning or service position. The system has been distributed worldwide.

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: FDA Class II device with a potential defect in a safety-critical component. The locking mechanism failure presents a risk of harm if the mechanism fails to secure the gantry during scanning or maintenance; however, no illnesses or injuries have been reported, making this a theoretical risk-of-harm scenario.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the SIEMENS Biograph Horizon 3R Mobile, a positron emission tomography (PET) and computed tomography (CT) imaging system used in medical facilities for diagnostic scanning.

The recall is issued due to a potential defect in the locking mechanism that secures the PET gantry in either its scanning position or service position. A failure of this locking mechanism could create a safety hazard.

The affected system has been distributed worldwide, including in the United States, Japan, Chile, and Australia.

Facilities operating this equipment should contact Siemens Medical Solutions USA, Inc. for guidance regarding repair or replacement. The system can be identified by Material Number 10532746, Serial Number 94792, and UDI/DI 405686901102894792.

The recalled product

Product: SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
Manufacturer: Siemens Medical Solutions USA, Inc.
Category: Medical Device — Imaging System / PET-CT Scanner
Hazard: locking-failure
fall-hazard
Affected units: 1

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 (3)

UDI/DI 405686901102894792
Material Number 10532746
Serial Number 94792

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Siemens Medical Solutions USA, 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 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc.

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