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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:137821

Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar.

Official recall number

Z-1986-2015

Evidence summary

Product code
ISD
Recall status
Terminated
Event initiated
April 09, 2015
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1986-2015

Field note

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