FDA recall Z-3178-2018

Product

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.

Reason for recall

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.

Distribution

Worldwide Distribution - US Nationwide

Key facts

Status

Terminated

Initiation date

2018-08-15

Report date

2018-09-26

Termination date

2021-05-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Timra, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3178-2018