Elekta ERGO++ Medical Device Recall for Incorrect DICOM Mapping
Elekta Inc is recalling 182 ERGO++ devices due to incorrect DICOM mapping of collimator or couch angles, which may lead to incorrect rotation during planning.
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 high-risk medical device where a defect could lead to incorrect treatment delivery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Elekta Inc is recalling 182 units of the ERGO++ medical device. The recall is due to a software issue involving the incorrect DICOM mapping of exported collimator or couch angles. This defect may lead to incorrect rotation of the collimator or couch when using a multi-leaf collimator (MLC) device for treatment planning.
The affected devices are version 1.7.3 and higher. The recall covers devices distributed worldwide, including in the United States and numerous international locations. The source text does not specify the exact number of patients affected or report any specific injuries or illnesses resulting from this defect.
Healthcare providers should contact Elekta Inc for instructions on how to resolve the issue. Consumers and patients should consult their healthcare providers for guidance regarding their specific treatment plans and any necessary corrective actions.
The recalled product
- Product
- Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
- Manufacturer
- Elekta Inc
- Affected units
- 182
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 (1)
- Version 1.7.3 and higher
Distribution
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