Siemens Biograph 6 TruePoint PET/CT Recall for Missing Instructions
Siemens is recalling 18 Biograph 6 TruePoint mobile PET/CT systems because mobile-specific instructions were not shipped to a limited population.
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 limited to missing documentation (mobile-specific instructions) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling 18 units of the Biograph 6 TruePoint mobile PET/CT system (Material Number 10097289). The recall is due to the omission of mobile-specific instructions that were not shipped to a limited population of these systems.
The affected devices are distributed worldwide, including in the United States and in Switzerland, Great Britain, and Italy. The specific serial numbers or codes for the affected units are 1010, 1024, 1038, 44976, 45509, 45530, 45573, 45583, 45601, 45604, 45619, 45621, 45627, 45639, 45640, 45646, 45655, and 45658.
Healthcare professionals using these devices should contact Siemens Medical Solutions USA Inc. for further instructions on how to obtain the missing documentation. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Biograph 6 TruePoint, Material Number 10097289 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 purpose of d
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
- Affected units
- 18
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 (18)
- 1010
- 1024
- 1038
- 44976
- 45509
- 45530
- 45573
- 45583
- 45601
- 45604
- 45619
- 45621
- 45627
- 45639
- 45640
- 45646
- 45655
- 45658
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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