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.
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 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.
- 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
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.
See all →- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · structural defect
See all →- SevereSubaru Recalls 2026 Forester and Crosstrek for Ball Joint Defect
NHTSA · 2026-10-19
- Severe
- SevereVolvo Recalls 2025-2026 VNL Trucks for Loose Structural Bolts
NHTSA · 2026-10-15
- Severe
- Severe
Similar recalls
- HighSiemens e.cam Gamma Camera Recall for Radial Brake Failure
FDA (Devices) · 2015-11-11
- ModerateSiemens e.cam camera systems recalled for loose rear casters
FDA (Devices) · 2014-07-23
- HighSiemens e.cam and Symbia E Gamma Camera Patient Bed Recall
FDA (Devices) · 2016-09-14
- ModerateSiemens E.cam and Symbia Systems Recalled for Detector Time Loss
FDA (Devices) · 2020-09-02
- LowSiemens e.cam Gamma Camera Recall for Missing Operator Manuals
FDA (Devices) · 2016-01-27
- ModerateSiemens Symbia E Camera System Recalled for Loose Rear Casters
FDA (Devices) · 2014-07-23