The Recall Desk
HighFDA (Devices)·Z-0911-2015·Announced 2015-01-14

Siemens Symbia S Series Medical Imaging Systems Recalled for Detector Motion

Siemens is recalling 877 Symbia S series imaging systems due to reports of unintended detector motion that may cause patient compression injuries.

What this means for you

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 risk of patient injury (compression) without reported fatalities or hospitalizations, 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 877 units of the Siemens Symbia S series medical imaging systems. These systems are intended for use by trained health care professionals to aid in detecting, localizing, diagnosing, staging, and restaging of lesions, tumors, disease, and organ function.

The recall was initiated after Siemens received reports of unintended radial motion of the detectors. The company states that this unintended motion, should it occur, may cause patient compression-related injuries.

The affected systems were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Health care facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect.

The recalled product

Product
The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limit
Manufacturer
Siemens Medical Solutions USA, Inc.
Category
Medical Device — Imaging Systems
Hazard
Affected units
877

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 S
  • Product Number: 8717741
  • Serial Numbers: 1001
  • 1002
  • 1003
  • 1005
  • 1006
  • 1007
  • 1008
  • 1009
  • 1010
  • 1011
  • 1012
  • 1013
  • 1014
  • 1015
  • 1016
  • 1017
  • 1018
  • 1019

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same manufacturer · Siemens Medical Solutions USA, Inc.

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Same hazard · compression injury

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