Elekta, Inc. recalls Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam ra…
- Recall date
- October 16, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0181-2016
- FDA classification
- Class II
- Brand / firm
- Elekta, Inc.
- Sold / distributed
- CA, IN, MI,MO, TX, WI, Australia, Canada, Germany,m Greece, India, Netherlands, New Zealand, Turkey and United Kingdom
Why it was recalled
Unintended update of Dose and MU and Incorrect Assignment of Bolus.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
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