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.
- Hazard
- locking-failure
- fall-hazard
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.
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