The Recall Desk
HighFDA (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.

What this means for you

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
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 →

Related recalls

Same manufacturer · Siemens Medical Solutions USA, Inc.

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Same hazard · locking failure

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