Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1296-2015·Announced 2015-03-25

Siemens Symbia E SPECT Systems Recalled for Incorrect Radial Motor Assembly

Siemens Medical Solutions is recalling 419 Symbia E SPECT systems worldwide because radial motor drives were incorrectly assembled backwards during a customer service action.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source text describes a mechanical assembly error (motors assembled backwards) without reporting any injuries, illnesses, or deaths. Per the rubric, a Class II recall without reported hospitalizations or significant injuries falls under Moderate severity.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 419 Symbia E multi-purpose SPECT systems distributed worldwide. The recall involves both Dual Head and Single Head system configurations.

The recall was initiated because radial motor drives that were replaced during a customer service action were incorrectly assembled backwards. This defect affects the mechanical operation of the imaging system.

The affected units are distributed in the United States and numerous countries worldwide. Siemens Medical Solutions is the recalling firm. No specific instructions for consumers or healthcare providers are provided in the source text beyond the identification of the defect.

The recalled product

Product: Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
Manufacturer: Siemens Medical Solutions USA, Inc.
Category: Medical Device — Imaging Equipment
Hazard: mechanical-defect
Affected units: 419

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 (20)

1) Symbia E Dual Head System
Material Number: 10275879
Serial Numbers: 1001
1002
1003
1004
1005
1006
1007
1008
1009
1010
1011
1012
1013
1014
1015
1016
1017
1018

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc.

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