Siemens Biograph mCT PET/CT Scanners Recalled for Plug Overheating Risk
Siemens Medical Solutions is recalling 890 Biograph mCT PET/CT scanners because plug terminals may become loose and overheat.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a risk of overheating and potential fire, which constitutes a significant injury or property-damage report criterion under the rubric for Severe (Score 4) hazards, even without explicit reported injuries in the text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 890 units of the Biograph mCT combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners. The recall covers multiple model variations, including the S(64)-3R, S(20)-3R, Flow 20-4R, and m Flow 64-4R, among others.
The recall was initiated because the terminals on the plug may become loose and overheat. This defect poses a potential fire or burn hazard to the equipment and surrounding area. The affected units were distributed worldwide, including in the United States and numerous international locations such as Canada, the United Kingdom, Germany, and Japan.
Healthcare facilities and users of these scanners should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. The company is responsible for managing the recall and providing necessary repairs or replacements to ensure the safety of the medical devices.
The recalled product
- Product
- Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT S(20
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 890
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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