Oncology software recalled because appended medication orders may mismatch the schedule
Elekta is recalling four systems running MOSAIQ Oncology Information System builds 3.1.3 through 3.2.3.0 because appended wave medication orders may not match the intended schedule.
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: Scored 3 under the risk-of-harm criterion: medication orders scheduled differently from what was intended can affect treatment, and no injuries are reported.
Plain-English summary
The MOSAIQ Oncology Information System, software builds 3.1.3, 3.2.1, 3.2.2 and 3.2.3.0, from Elekta Solutions, is being recalled.
When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
The recall covers 4 systems containing the affected software, distributed in New Mexico and to Canada, Malta and South Africa. The FDA has classified the action as Class II.
Medication orders that do not follow the intended schedule can affect how treatment is delivered. The enforcement record reports no injuries. Sites running an affected build should follow Elekta's instructions.
The recalled product
- Product
- MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3…
- Manufacturer
- ELEKTA SOLUTIONS AB
- Affected units
- 4
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)
- Software Versions: 3.1.3
- 3.2.1
Distribution
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