The Recall Desk
ModerateFDA (Devices)·Z-1297-2015·Announced 2015-03-25

Siemens E.CAM Systems Recalled for Incorrectly Assembled Radial Motor Drives

Siemens Medical Solutions is recalling E.CAM emission computed tomography systems because radial motor drives replaced during service were assembled backwards.

What this means for you

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any injuries, illnesses, or deaths, and the defect is a mechanical assembly error rather than a high-risk pathogen or structural failure leading to immediate severe harm.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling E.CAM emission computed tomography systems used to detect or image the distribution of radionuclides in the body or organ. The recall involves 4,856 systems distributed worldwide, including the United States and numerous international countries.

The recall is due to radial motor drives that were replaced during a customer service action being incorrectly assembled backwards. This assembly error is the specific defect identified in the recall notice.

Healthcare facilities and users of these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the incorrectly assembled components.

The recalled product

Product
E.CAM emission computed tomography 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
Affected units
4,856

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) E.CAM gantry single head
  • Material Number: 4380213
  • Serial Numbers: 1
  • 2
  • 1002
  • 1003
  • 1004
  • 1005
  • 1006
  • 1007
  • 1008
  • 1009
  • 1010
  • 1011
  • 1012
  • 1013
  • 1014
  • 1015
  • 1016
  • 1017

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 →

Related recalls

Same manufacturer · Siemens Medical Solutions USA, Inc.

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Same hazard · mechanical defect

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