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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:116759

SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.0, Part No. 8139847, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

Official recall number

Z-1044-2013

Evidence summary

Product code
IYE
Recall status
Terminated
Event initiated
Unavailable
Root cause
Software design (manufacturing process)
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1044-2013

Field note

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