Agency classClass IIOur severity:High FDA (Devices)·Z-0914-2015·Announced 2015-01-14

Siemens e.cam Systems Recalled for Potential Patient Finger Injury

Siemens Medical Solutions is recalling 4,462 e.cam emission computed tomography systems due to a potential risk of patient finger injury.

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 risk-of-harm product (potential patient finger injury) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 4,462 e.cam emission computed tomography systems. These devices are used to detect or image the distribution of radionuclides in the body or organ using planar imaging, whole body imaging, and tomographic imaging for isotopes with energies up to 588keV.

The recall is being issued because there is a potential for patient finger injury on the affected systems. The source text does not specify the exact mechanical cause of the injury or report any confirmed incidents of harm.

The affected units were distributed worldwide, including nationwide in the United States and in numerous countries across multiple continents. The recall covers various specific models and serial numbers of the e.cam system, including DCR Duet Head, DCR Gantry Dual Head, and Signature E.CAM models. Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this safety issue.

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 588keV.
Manufacturer: Siemens Medical Solutions USA, Inc.
Category: Medical Device — Imaging Equipment
Hazard: pinch-injury
Affected units: 4,462

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 DCR Duet Head
A (e.soft)
Serial Numbers: 7090
7501
7502
8001
8002
8003
8004
8501
8502
8506
8507
2) E.CAM DCR Gantry Dual Head
Bl Serial Numbers: 3097
8508
8509
8510
8511
8514

Distribution

Distributed nationwide across the United States.

The notice also names 43 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc.

See all →

Moderate
ARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
High
ARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
Moderate
ARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
High
ARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
High
ARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10

Same hazard · pinch injury