Elekta Recalls DMLC IV-ERGO Systems Due to Gantry Sensor Error
Elekta, Inc. is recalling 35 DMLC IV-ERGO systems because an intermittent error may occur in the gantry sensor. The devices are used with linear accelerators for radiation therapy.
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 is classified as FDA Class II. The hazard involves a potential sensor error in a medical device used for radiation therapy, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Elekta, Inc. is recalling 35 units of the DMLC IV-ERGO product. This device is intended for use with rotating gantry linear accelerators to conform radiation dose delivery to specific geometrical volumes containing pathology, while sparing adjacent non-diseased tissues.
The recall is being issued because it is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems. The affected units were distributed nationwide in the states of Connecticut, Florida, Georgia, Iowa, Missouri, New York, North Dakota, Oklahoma, Rhode Island, Texas, Virginia, and Washington.
Healthcare facilities that have purchased or received these devices should contact Elekta, Inc. for further instructions on how to proceed with the recall. The specific identifiers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
- Manufacturer
- Elekta, Inc.
- Affected units
- 35
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 (17)
- Identifier : 116001
- 116012
- 116044
- 116055
- 116014
- 116052
- 116023
- 116056
- 116053
- 116043
- 116047
- 116051
- 116122
- 116063
- 116068
- 116013
- 116046
Distribution
Related recalls
Same manufacturer · Elekta, Inc.
See all →- SevereBrachytherapy Applicator Advanced Gynecological Applicator Tip Detachment
FDA (Devices) · 2026-07-15
- SevereFletcher CT/MR Shielded Applicator Set for Gynecological Brachytherapy Recalled
FDA (Devices) · 2026-07-15
- SevereElekta Geneva Brachytherapy Applicator Intrauterine Tube Detachment Risk
FDA (Devices) · 2026-07-15
- HighMOSAIQ oncology software may fail to load adapted treatment plan
FDA (Devices) · 2026-06-17
- HighLeksell Vantage Arc System locking mechanism may not secure properly
FDA (Devices) · 2026-05-06
Same hazard · sensor error
See all →- ModerateHemodynamic recording systems recalled over pressure sensor error during blood pressure measurement
FDA (Devices) · 2025-09-10
- HighTesla Model 3 Forward Collision Avoidance System Software Error
NHTSA · 2021-10-29
- ModeratePhadia 1000 Immunodiagnostic Instruments Recalled for Liquid Sensor Error
FDA (Devices) · 2019-09-04
Similar recalls
- HighElekta Recalls DMLC IV-ERGO Beam Shaping Blocks for Radiation Therapy
FDA (Devices) · 2013-09-11
- HighElekta ERGO++ Medical Device Recall for Incorrect DICOM Mapping
FDA (Devices) · 2017-12-20
- HighElekta Precise Digital Accelerator Recall for Potential Securing Bolt Failure
FDA (Devices) · 2015-02-18
- HighElekta Desktop Pro Linear Accelerator Control Software Recalled for Calibration Errors
FDA (Devices) · 2014-03-12
- ModerateElekta Digital Accelerators Recalled for Default Value Reset Issues
FDA (Devices) · 2014-03-12
- HighElekta Recalls HexaPOD evo RT Systems for Positioning Errors
FDA (Devices) · 2016-09-07