Siemens CT Systems Recalled for Missing Locking Ring on Ceiling Mounts
Siemens Medical Solutions is recalling specific CT systems because optional ceiling mounts may be missing a locking ring.
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 SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743. The recall involves a specific unit with Serial Number 11004.
The recall is being conducted because emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring. This missing component could affect the stability of the ceiling mount.
The affected unit was distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland. Users of this equipment should contact Siemens Medical Solutions USA Inc. for further instructions regarding the missing locking ring.
The recalled product
- Product
- SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743
- Manufacturer
- Siemens Medical Solutions USA Inc.
- 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 11004
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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