Recall Z-3178-2018— Permobil, Ab
Class II · Terminated
Class II FDA medical device recall by Permobil, Ab, initiated 2018-08-15, terminated 2021-05-03. It names 4 FDA 510(k) clearances: K123290, K071650, K041219 and 1 more. 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: 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..
- Recalling firm
- Permobil, Ab
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-15
- Terminated
- 2021-05-03
- Firm location
- Timra, N/A, Sweden
510(k) clearances named in this recall
4 on FDA's record- K123290 — M300 & M400
- K071650 — C350 POWERED WHEELCHAIR
- K041219 — ELECTRO
- K991658 — PERMOBIL POWERED WHEELCHAIR 1280
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.