Siemens Biograph Mobile PET/CT Recall for Missing Instructions
Siemens is recalling nine Biograph Mobile PET/CT systems because mobile-specific instructions were not shipped to a limited population of devices.
What this means for you
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, but the hazard is a missing documentation component (instructions) rather than a direct physical defect or contamination, fitting the criteria for moderate severity involving documentation issues or low-risk scenarios.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling nine Biograph 16 TruePoint - 3R Mobile PET/CT systems (Material Number 10249555). The recall was initiated because the mobile-specific instructions were not shipped to a limited population of these systems.
The affected devices were distributed worldwide, including in the United States (CA, CT, FL, GA, IL, KY, MA, MI, ND, NJ, OH, OK, OR, PA, TN, WA, WI, WY) and in Switzerland, Great Britain, and Italy. The specific serial numbers for the affected units are 72444, 72470, 72476, 72480, 72487, 72494, 72515, 72526, and 72545.
Healthcare professionals who own or use these devices should contact Siemens Medical Solutions USA Inc. to obtain the missing instructions. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpos
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
- Affected units
- 9
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 (9)
- 72444
- 72470
- 72476
- 72480
- 72487
- 72494
- 72515
- 72526
- 72545
Distribution
Part of a larger recall action
This product is one of 4 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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