Elekta MOSAIC Oncology Information System versions: 2.62… recallZ-1783-2021 · Elekta, Inc. · initiated Apr 20, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Elekta, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Malware attack
FDA root cause category: Under Investigation by firm
What the company is doing
The firm notified the users by telephone on 04/20/2021 and followed with a written notice disseminated by email on 04/22/2021. For questions contact your Elekta Representative.
Recall details
- Recall number
- Z-1783-2021
- Status
- Terminated
- Initiated by the company
- Apr 20, 2021
- Recalling firm
- Elekta, Inc.
- Quantity
- 40 units
- Product code
- IYE
- FDA submissions
- K141572, K183034
- Distribution
- Nationwide
Product description
Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
Code information (models, lots, serial numbers)
v2.62 - no UDI, v2.64 - 00858164002091, v2.70 - 00858164002237, v2.81 - 00858164002282, v2.82 - 00858164002336, v2.83 - 00858164002367
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- MOSAIQElekta, Inc. · Accelerator, Linear, Medical3 recalls112 reports
- MOSAIQElekta Solutions AB · Accelerator, Linear, Medical2 recalls83 reports
- MOSAIQElekta Solutions AB · Accelerator, Linear, Medical2 recalls60 reports
- MOSAIQElekta, Inc. · Accelerator, Linear, Medical2 recalls0 reports
- MOSAIQElekta Solutions AB · Accelerator, Linear, Medical1 recall12 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K141572, K183034 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- MOSAIQElekta Solutions AB · Accelerator, Linear, Medical1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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