Agency classClass IIOur severity:High FDA (Devices)·Z-2332-2015·Announced 2015-08-12

Siemens Biograph mCT S(64)-4R PET/CT Systems Recalled for Missing Locking Ring

Siemens Medical Solutions USA Inc. is recalling one Biograph mCT S(64)-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 is classified as FDA Class II and involves a structural defect (missing locking ring) on a ceiling mount, which presents a risk of harm (potential fall of equipment) even though no injuries are reported in the source text.

Plain-English summary

Siemens Medical Solutions USA Inc. is recalling one unit of the Biograph mCT S(64)-4R, Model Number 10248672, serial number 11026. 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 was distributed in the state of Texas and in the countries of Germany, France, Russia, Denmark, and Switzerland. The recall is classified as Class II by the U.S. Food and Drug Administration.

Facilities with this specific unit should contact Siemens Medical Solutions USA Inc. for instructions on how to resolve the issue. The source text does not specify the exact action required, such as repair or replacement, but indicates the need to address the missing component.

The recalled product

Product: Biograph mCT S(64)-4R, Model Number 10248672
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 11026

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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