Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2042-2014·Announced 2014-07-23

Siemens e.cam camera systems recalled for loose rear casters

Siemens Medical Solutions USA is recalling 2,458 e.cam camera systems because the collimator cart rear casters may become loose.

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, and the hazard involves loose casters on a cart, which presents a risk of harm but is not a structural defect of the imaging device itself nor associated with reported injuries in the source text.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 2,458 e.cam camera systems, which are Emission Computed Tomography Systems used for nuclear medicine diagnostics. The recall was initiated after the company received reports indicating that the collimator cart rear casters may become loose.

The affected systems were distributed worldwide, including nationwide in the United States and in numerous foreign countries. The recall covers various models and serial numbers of the e.cam camera system, including E.CAM Single Head, Dual Head, Gantry, and Signature E.CAM configurations.

Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the issue with the loose rear casters on the collimator cart.

The recalled product

Product: e.cam camera system. 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. Nuclear…
Manufacturer: Siemens Medical Solutions USA, Inc.
Category: Medical Device — Nuclear Medicine Imaging
Hazard: mechanical-failure
Affected units: 2,458

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 Single Head (ICON S)
Model Number: 4380213
Serial Numbers: 2005
3027
1012
1018
2018
3028
3004
2) E.CAM Dual Head (ICON S)
Model Number: 4380221
Serial Numbers: 1012
5090
1022
1037
1099
1201
1127
1091
1023

Distribution

Distributed nationwide across the United States.

The notice also names 52 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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