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Siemens Medical Solutions USA, Inc Recall 89228

Description: ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815

Siemens Medical Solutions USA, Inc Recall 89228 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0441-2022
Event ID89228
Event DescriptionARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
Product TypeDevices
DistributionUS Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD.
Quantity13 units
Recall ReasonPotential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury
Device Classification20220105
Device Code InfoSerial Numbers: 10085 10524 10737 10736 10586 10792 10793 10822 10843 10850 10886 10865 11122 UDI: 040568691613655911
Center Classification Date20211229
Recall Initiation Date20211209
Recalling FirmSiemens Medical Solutions USA, Inc
Initial Notification Letter
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