Elekta Inc Recall 88451
Description: Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Elekta Inc Recall 88451 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2406-2021 |
| Event ID | 88451 |
| Event Description | Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 |
| Product Type | Devices |
| Distribution | Distribution in US - IA, NJ, NY, TN, PA, TX, and WI OUS distribution in Australia, Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom |
| Recall Reason | If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams. |
| Device Classification | 20210908 |
| Device Code Info | Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10 UDI: (01)00858164002190(10) 5.40.00 (01)00858164002190(10) 5.40.01 (01)00858164002190(10) 5.40.02 (01)00858164002268(10) 5.51.10 |
| Center Classification Date | 20210902 |
| Recall Initiation Date | 20210726 |
| Recalling Firm | Elekta Inc |
| Initial Notification | Letter |
| Similar To |