Siemens Biograph Horizon PET/CT System Recalled for Design Defects
Siemens Medical Solutions USA is recalling 171 Biograph Horizon PET/CT systems worldwide due to improper design or specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. No specific injuries, illnesses, or deaths are reported in the source text, and the defect is described generally as improper design or specifications.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 171 units of the Siemens Biograph Horizon PET/CT System. These devices are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners used to provide registration and fusion of high-resolution physiologic and anatomic information.
The recall was initiated due to improper design or specifications. The affected units are distributed worldwide, including in the United States and numerous international locations such as Argentina, Australia, Brazil, China, France, Germany, India, Japan, and the United Kingdom.
Healthcare facilities and users should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and remediation of the affected devices.
The recalled product
- Product
- Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 171
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 (20)
- Material Number: 10532746 - Serial #'s: 94401
- 94405
- 94406
- 94408
- 94409
- 94413
- 94414
- 94415
- 94420
- 94421
- 94422
- 94423
- 94424
- 94425
- 94426
- 94427
- 94429
- 94430
- 94431
- 94432
Distribution
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