Siemens Biograph mCT-S(64) 4R PET/CT Scanners Recalled for Cover Bracket Defect
Siemens Medical Solutions USA Inc. is recalling two Biograph mCT-S(64) 4R PET/CT scanners because a cover bracket may not be welded, posing a risk of the cover falling during service.
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 3/5 (High).
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 structural defect in a medical device that could cause a heavy cover to fall during service, presenting a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling two units of the Biograph mCT-S(64) 4R, Material Number 10248672. These 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 is due to a defect in the bracket used to lift the cover. The bolts on this bracket were not welded, which could potentially cause the cover to fall down during service. The affected units have serial numbers 31125 and 31126.
The affected units were distributed worldwide, including the United States, China, and Malaysia. Siemens Medical Solutions USA Inc. is the recalling firm. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 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…
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Affected units
- 2
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 (2)
- Serial Numbers: 31125
- 31126
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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