Impac Medical MOSAIQ Oncology System Recall for Wedge Motor Unit Error
Impac Medical is recalling MOSAIQ Oncology Information Systems due to a software error that incorrectly resets remaining Wedge Motor Units to zero after a machine fault.
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: The recall is classified as FDA Class II. The hazard involves a software error in a medical device used for radiation therapy, which poses a risk of harm to patients if the treatment parameters are incorrectly recorded, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Impac Medical Systems Inc is recalling MOSAIQ Oncology Information Systems, an image-enabled electronic medical record system used for oncology workflow management. The recall affects systems interfaced with Elekta Treatment machines. The issue involves a software defect where, if the system resumes after a machine terminates or faults, the remaining Wedge Motor Units are erroneously set to zero.
The recall covers Version 2.10 (all builds) and Version 2.20 (builds up to and including 2.20.07A7). The affected products were distributed worldwide, including in the United States (specifically Virginia, Connecticut, Georgia, New Jersey, and New York) and in Belgium, Denmark, France, and the United Kingdom. A total of 11 affected sites are identified in the recall notice.
This recall is classified as Class II by the FDA. Users of the affected systems should contact Impac Medical Systems for further instructions on resolving the software issue.
The recalled product
- Product
- MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086
- Manufacturer
- Impac Medical Systems Inc
- Affected units
- 11
Distribution
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