Class 2 Device Recall efix E19 power drive

• Date Initiated by Firm: August 01, 2004
• Date Posted: May 06, 2005
• Recall Status: Terminated on August 23, 2006
• Recall Number: Z-0803-05
• Recall Event ID: 31773
• 510(K)Number: K943789
• Product Classification: Wheelchair, Powered - Product Code ITI
• Product: e-fix E19 power drive. The product is a wheelchair component/accessory.
• Code Information: Model number E19
• Recalling Firm/ Manufacturer: Frank Mobility Systems, Inc.; 1003 International Dr; Oakdale PA 15071-9226
• For Additional Information Contact: Jennifer Fetcko; 724-695-3710
• Manufacturer Reason for Recall: may short circuit within the interface due to long term exposure of liquid
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 314 units
• Distribution: The products were shipped to distributors nationwide. The product was also shipped to Mexico and Panama.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = ITI