Recall Z-0006-2018— Permobil, Ab

Name: FDA recall Z-0006-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-01

Class II · Terminated

Class II FDA medical device recall by Permobil, Ab, initiated 2017-09-01, terminated 2021-05-04. It names 3 FDA 510(k) clearances: K071650, K041219, K991658. Product: Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500. Reason: 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..

Recalling firm: Permobil, Ab
Classification: Class II
Status: Terminated
Initiated: 2017-09-01
Terminated: 2021-05-04
Firm location: Timra, N/A, Sweden

510(k) clearances named in this recall

3 on FDA's record

K071650 — C350 POWERED WHEELCHAIRPermobil AB·cleared 2007-09-12
K041219 — ELECTROPermobil AB·cleared 2004-08-04
K991658 — PERMOBIL POWERED WHEELCHAIR 1280Permobil AB·cleared 1999-10-08

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

Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.