Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts
Siemens is recalling one Biograph mCT scanner because unwelded bolts on the cover-lifting bracket could cause the cover to fall during service.
What this means for you
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 where injury has not yet been reported, fitting the High severity criteria for potential physical injury from a falling component.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling one unit of the BIOGRAPH mCT S(20) - 4R scanner, material number 10528958, serial number 11022. The product is a combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanner.
The recall was initiated because the bracket used to lift the cover has bolts that were not welded in. This defect potentially causes the cover to fall down during service.
The affected unit was distributed worldwide, including the United States, China, and Malaysia. Siemens is the recalling firm.
The recalled product
- Product
- BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT 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 infor
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
- Affected units
- 1
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 (1)
- Serial Number 11022
Distribution
Distributed nationwide across the United States.
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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