MOSAIQ Oncology Information System software defect reverts approved drug strength
The MOSAIQ Oncology Information System has a software defect where approved changes to drug strength revert to the original value when saved, potentially resulting in incorrect medication dosages.
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: FDA Class II medical device with a software defect that could cause medication dosing errors in oncology treatment. No illnesses, injuries, or deaths reported. Qualifies as risk-of-harm product without reported injury per severity rubric.
Plain-English summary
Elekta, Inc. is recalling the MOSAIQ Oncology Information System due to a software defect in version 2.83. The defect affects the drug strength field in the medication ordering process.
When users change a drug strength value during the ordering process and approve the change, the system does not persist the modification. Instead, the saved drug strength reverts to the original value. This inconsistency between the approved value and the saved value could result in patients receiving incorrect medication dosages.
Affected facilities are located in California, Colorado, Florida, Idaho, Louisiana, Missouri, Mississippi, North Carolina, New Hampshire, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, and Washington. The system was also distributed to Australia, Canada, and the United Kingdom.
The recalled product
- Product
- MOSAIQ Oncology Information System
- Manufacturer
- Elekta, Inc.
- Affected units
- 31
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)
- MOSAIQ 2.83 when run with First Data Bank (FDB)
- UDI/GTIN MOSAIQ 2.83 (0858164002367)
Distribution
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