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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:180473

Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill. The device will be used as an assistive device for gait deficiency rehabilitation and research purposes.

Official recall number

Z-2135-2020

Evidence summary

Product code
BXB
Recall status
Open, Classified
Event initiated
July 29, 2019
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2135-2020

Field note

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