Agency classClass IIOur severity:High FDA (Devices)·Z-2331-2015·Announced 2015-08-12

Siemens Biograph mCT S(40)-4R Recall for Missing Locking Ring

Siemens is recalling one Biograph mCT S(40)-4R unit because it may be missing a locking ring on the optional ceiling mount.

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) on a medical device with an optional ceiling mount, which poses a risk of harm (falling equipment) even though no injuries have been reported. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA Inc. is recalling one unit of the Biograph mCT S(40)-4R, Model Number 10248671. The recall is due to a potential defect where the emission computed tomography system or computed tomography xray system with an optional ceiling mount may be missing a locking ring.

The affected unit, identified by Serial Number 11073, was distributed in the state of Texas and in the countries of Germany, France, Russia, Denmark, and Switzerland. The source text does not specify the exact number of units affected beyond the single unit identified by serial number, nor does it report any injuries or illnesses associated with this defect.

Healthcare facilities and consumers should check their equipment for the presence of the locking ring on the optional ceiling mount. If the ring is missing, the equipment should be taken out of service and the manufacturer contacted for further instructions.

The recalled product

Product: Biograph mCT S(40)-4R, Model Number 10248671
Manufacturer: Siemens Medical Solutions USA Inc.
Category: Medical Device — Imaging Equipment
Hazard: structural-defect
falling-object
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 11073

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.

See all 8 products in this recall →

Same manufacturer · Siemens Medical Solutions USA Inc.

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