Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2898-2020·Announced 2020-09-02

Siemens E.cam and Symbia Systems Recalled for Detector Time Loss

Siemens Medical Solutions is recalling E.cam and Symbia systems with foresight detectors because they may lose detector time information during gated or dynamic acquisitions.

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 source text explicitly states that the probability of the defect occurring is remote, fitting the criteria for a moderate severity rating involving low-risk or precautionary issues.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 5,066 E.cam and Symbia systems equipped with foresight detectors. The recall is due to a defect where the systems may lose some detector time information when performing gated or dynamic acquisitions. The affected systems are used for SPECT, CT, and SPECT+CT imaging to detect or image the distribution of radionuclides in the body or organ.

The company's risk analysis indicates that the probability of this occurrence is remote. The systems were distributed nationwide across the United States, including all 50 states, the District of Columbia, and Puerto Rico. Specific model numbers and serial numbers for the affected E.cam and Symbia series are listed in the official recall documentation.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.

The recalled product

Product: E.cam or Symbia systems that use foresight detectors - Product Usage: 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 Systems
Hazard: data-loss
imaging-error
Affected units: 5,066

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)

Model Numbers: 8717733
8717741
10275007
10275009
10275010
10607649
10764801
10764802
10764803
10764804
10275879
10413009
4380213
4380221
5242826
5977066
5977074
5984005
5989079
5989087

Distribution

Distributed nationwide across the United States.

The notice also names 50 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 · data loss