FDA-Device2017-10-11Class II

Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR

Permobil, Ab
Hazard

There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base.

Sold states
Nationwide and Australia, Benelux, Canada, Denmark, Finland, France, Germany, Israel, Norway, Sweden, and UAE
Affected count
5539 units
Manufactured in
Arvaltsvagen 10, Box 120, Timra, N/A, Sweden
Products
Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0005-2018

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