Siemens Biograph 64-3R PET/CT Systems Recalled for Missing Locking Ring
Siemens Medical Solutions is recalling Biograph 64-3R TruePoint systems because they may be missing a locking ring on optional ceiling mounts.
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 (missing locking ring) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling one unit of the Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301, emission computed tomography system. The recall is due to a potential defect where the system may be missing a locking ring on optional ceiling mounts.
The affected unit, identified by Serial Number 1020, was distributed in the state of Texas and in the countries of Germany, France, Russia, Denmark, and Switzerland. The source text does not report any injuries or illnesses associated with this defect.
Healthcare facilities should contact Siemens Medical Solutions USA Inc. to verify if their equipment is affected and to arrange for the necessary repair or replacement of the missing locking ring.
The recalled product
- Product
- Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301
- 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 1020
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 8 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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