Siemens Biograph Horizon PET/CT Scanners Recalled for Plug Overheating Risk
Siemens Medical Solutions is recalling 78 Biograph Horizon PET/CT scanners because loose plug terminals may overheat.
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: The recall involves a risk-of-harm product (overheating electrical components) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 78 units of the Biograph Horizon PET/CT scanners, specifically the 3R (Material Number 10532746) and 4R (Material Number 10532748) models. The recall is due to a defect where the terminals on the plug may become loose and overheat.
The affected devices were distributed worldwide, including in the United States and numerous international markets. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. to arrange for the necessary corrective actions or repairs to address the potential overheating hazard.
The recalled product
- Product
- Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 78
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
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