The Recall Desk
HighFDA (Devices)·Z-0116-2015·Announced 2014-10-29

Siemens e.cam Gamma Camera Systems Recalled for Loose Bolts

Siemens Medical Solutions is recalling e.cam gamma camera systems due to reports of loose bolts in the detector support structure.

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 involves a structural defect (loose bolts) in a medical device that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 4,862 e.cam line gamma camera systems. These devices are used to detect or image the distribution of radionuclides in the body or organ.

The recall was initiated 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 instructions on how to address the defect. The source text does not specify a corrective action, such as repair or replacement, or provide specific contact details.

The recalled product

Product
e.cam line of gamma camera systems 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
Affected units
4,862

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: 10151531
  • Serial Numbers: 1002
  • 1003
  • 1004
  • 1005
  • 1006
  • 1007
  • 1008
  • 1009
  • 1010
  • 1011
  • 1012
  • 1013
  • 1014
  • 1015
  • 1016
  • 1017
  • 1018
  • 1019
  • 1020

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 →

Related recalls

Same manufacturer · Siemens Medical Solutions USA, Inc.

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Same hazard · structural defect

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