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Terminated

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.

FDA Recall Z-3178-2018 · Posted None

Recalling FirmPermobil, Ab
Recall StatusTerminated
Product CodeITI
Date Initiated2018-08-15
Date Terminated2021-05-03
Product Quantity3134 units

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.

Firm Action

The firm initiated the recall on 08/15/2018 by letter to the direct accounts (dealer/distributors). The letter instructed the consignee to contact the end users and perform the correction.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123290M300 & M400Permobil AB · 2013-04-17K071650C350 POWERED WHEELCHAIRPermobil AB · 2007-09-12K041219ELECTROPermobil AB · 2004-08-04K991658PERMOBIL POWERED WHEELCHAIR 1280Permobil AB · 1999-10-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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