Elekta MOSAIC Oncology Information System Recalled Due to Malware Attack
Elekta recalled versions 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 of the MOSAIC Oncology Information System due to a malware attack. Forty units were distributed nationwide.
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: This is a Class II medical device recall for a malware attack on a medical information system with no reported illnesses or injuries. It qualifies as High severity under the risk-of-harm criterion: active malware in an oncology information system poses potential threats to data integrity and system reliability, even without reported patient harm.
Plain-English summary
Elekta, Inc. issued a voluntary recall of versions 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 of the MOSAIC Oncology Information System hosted on Classic Cloud. A total of 40 units were affected by this recall, distributed nationwide across the United States.
The reason for the recall was a malware attack discovered on the system. Elekta voluntarily initiated this Class II recall on April 20, 2021. The Food and Drug Administration confirmed the classification on June 2, 2021, and the recall was terminated on January 17, 2023.
Facilities using the affected versions should contact Elekta, Inc. for assistance with system remediation and security measures. The company is headquartered in Atlanta, Georgia.
The recalled product
- Product
- Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
- Manufacturer
- Elekta, Inc.
- Affected units
- 40
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 (6)
- v2.62 - no UDI
- v2.64 - 00858164002091
- v2.70 - 00858164002237
- v2.81 - 00858164002282
- v2.82 - 00858164002336
- v2.83 - 00858164002367
Distribution
Distributed nationwide across the United States.
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