Elekta Focal SIM Planning Software Recalled for Incorrect Patient Shift Directions
Elekta, Inc. is recalling Focal SIM Planning software versions 4.64.00 through 4.700 due to incorrect patient shift directions in printed reports.
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 medical device used for radiation therapy planning where a software error could lead to incorrect patient positioning. While no injuries are reported, the potential for harm from misdirected radiation therapy places this in the High severity category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Elekta, Inc. is recalling Focal SIM Planning software, used for radiation therapy planning, in versions 4.64.00 through 4.700. The recall involves 38 units distributed nationwide to facilities in California, Connecticut, Florida, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Washington, and Wisconsin.
The recall is being conducted because the software may print incorrect patient shift directions in the Setup reference dialog when the DICOM coordinates option is enabled for reports. This error could potentially affect the accuracy of radiation therapy setup.
Healthcare facilities using this software should contact Elekta, Inc. for further instructions on how to address the issue. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Focal SIM Planning of radiation therapy
- Manufacturer
- Elekta, Inc.
- Affected units
- 38
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 (2)
- Version 4.64.00 - 4.700
- inclusive
Distribution
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