Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reported: November 4, 2015 Initiated: October 16, 2015 #Z-0181-2016
Product Description
Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason for Recall
Unintended update of Dose and MU and Incorrect Assignment of Bolus.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 154
- Distribution
- CA, IN, MI,MO, TX, WI, Australia, Canada, Germany,m Greece, India, Netherlands, New Zealand, Turkey and United Kingdom
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.. Recalled by Elekta, Inc.. Units affected: 154.
Why was this product recalled? ▼
Unintended update of Dose and MU and Incorrect Assignment of Bolus.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 4, 2015. Severity: Moderate. Recall number: Z-0181-2016.
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