Agency classClass IIOur severity:High FDA (Devices)·Z-0115-2015·Announced 2014-10-29

Siemens Symbia E SPECT Systems Recalled for Loose Bolts in Detector Support

Siemens Medical Solutions is recalling 562 Symbia E SPECT systems due to reports of loose bolts in the detector support structure.

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 (loose bolts) in a medical device, which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting 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 562 Symbia E multi-purpose SPECT systems. These devices are used in hospitals and outpatient centers to detect or image the distribution of radionuclides in the body or organ.

The recall is due to reports of loose bolts in the detector support structure of Symbia and E.CAM systems. The affected devices were distributed worldwide, including in the United States, its territories, and numerous international countries.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and corrective actions for the affected serial numbers.

The recalled product

Product: Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ.
Manufacturer: Siemens Medical Solutions USA, Inc.
Category: Medical Device — Imaging Equipment
Hazard: structural-defect
Affected units: 562

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) Part Number 10275879
Serial Numbers: 1001
1002
1003
1004
1005
1006
1007
1008
1009
1010
1011
1012
1013
1014
1015
1016
1017
1018
1019

Distribution

Distributed in 53 states:

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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