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Terminated

e-fix E20 power drive. The product is a wheelchair component/accessory.

FDA Recall Z-0804-05 · Posted 2005-05-06

Recalling FirmFrank Mobility Systems, Inc.
Recall StatusTerminated
Product CodeITI
Date Initiated2004-08-01
Date Terminated2006-08-23
Product Quantity314 units

Reason for Recall

may short circuit within the interface due to long term exposure of liquid

Firm Action

The recalling firm issued a Corrective Action Notice to their customers on 9/1/04 via certified mail return receipt. The notice described the problem and the correction (interface was designed). The notice also instructed the dealers/distributors to notify their customers and have the units brought back to them for the exchange.

Root Cause

Other

Distribution Pattern

The products were shipped to distributors nationwide. The product was also shipped to Mexico and Panama.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K943789POWER WHEELCHAIR CONVERSION KITAlber Technologies, Inc. · 1994-11-08

Official Source

View FDA Recall →

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

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