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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

Mandated?Voluntary: Firm initiated
Recall NumberZ-2406-2021
Event ID88451
Event DescriptionMonaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Product TypeDevices
DistributionDistribution 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 ReasonIf 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 Classification20210908
Device Code InfoSoftware 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 Date20210902
Recall Initiation Date20210726
Recalling FirmElekta Inc
Initial Notification Letter
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