FDA-Device2018-09-26Class II
Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e) C400 PS Product Usage: The devices identified are intended to provide outdoor and indoor mobility to persons limited to a seated position that can operate a powered wheelchair.
Permobil, Ab
Hazard
This correction decision has been made because of a potential failure of one or both backrest bars providing back support. If one or both back support telescoping bars fail the user could fall back leading to a potential injury.
Sold states
Worldwide Distribution - US Nationwide
Affected count
3134 units
Manufactured in
Arvaltsvagen 10, Box 120, Timra, N/A, Sweden
Products
Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e) C400 PS Product Usage: The devices identified are intended to provide outdoor and indoor mobility to persons limited to a seated position that can operate a powered wheelchair.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3178-2018Don't want to check this manually?
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