Monaco Radiation Treatment Planning System (RTP) System
- Company
- Elekta Inc
- Recall Initiated
- November 22, 2019
- Recall Number
- Z-0670-2020
- Quantity
- 76 (7 US, 69 OUS)
- Firm Location
- Saint Charles, MO
Reason for Recall
Monaco is using the incorrect energy when optimizing and calculating dose.
Distribution
IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.
Lot / Code Info
Software Builds: 5.40.00, 5.50.00 and 5.51.00. UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002244(10) 5.50.00, and (01)00858164002268(10) 5.51.00
Root Cause
Software Design Change
Action Taken
An Important Field Safety Notification letter is being emailed to affected customers beginning 11/22/2019. The letter identifies affected product, provides a description of the problem, and recommends user not use multiple energies within the same plan until a software fix has been applied to the device. A response form was asked to be returned. Affected customers are advised to contact local Elekta service teams for questions.