Elekta FOCAL Sim Workstation Software Recall for Plan Mismatch
Elekta is recalling FOCAL Sim Workstation software versions 4.70.00 and 4.80.00 because exported arc plans may not match approved treatment plans.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a significant risk of incorrect radiation treatment delivery, which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Elekta, Inc. is recalling 554 units of the FOCAL Sim Workstation, a Radiation Treatment Planning System used for patient contouring, viewing treatment plan outputs, and performing CT simulations. The recall affects software versions 4.70.00 and 4.80.00.
The recall is due to a software defect where, when exporting an arc plan (VMAT, Dynamic Conformal, or 3D Static Arcs) using the Composite Field Sequencing (CFS) feature, the exported DICOM plan does not match the approved treatment plan. This discrepancy could lead to incorrect treatment delivery if the exported plan is used for dose calculation.
The affected units were distributed worldwide, including in the United States (nationwide in specific states and Puerto Rico) and numerous international locations. Users of the affected software should contact Elekta, Inc. for instructions on how to resolve the issue and ensure treatment plans are accurate.
The recalled product
- Product
- FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
- Manufacturer
- Elekta, Inc.
- Affected units
- 554
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)
- Software versions 4.70.00 & 4.80.00
Distribution
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