Class 2 Device Recall Quickie/Zippie Powered Wheelchair

• Date Initiated by Firm: February 13, 2020
• Date Posted: May 11, 2020
• Recall Status: Terminated on April 28, 2021
• Recall Number: Z-1947-2020
• Recall Event ID: 85431
• 510(K)Number: K142457
• Product Classification: Wheelchair, powered - Product Code ITI
• Product: Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966).
• Code Information: Q700M wheelchair S/N Q7MP-083941. UDI:(01)05022408059799. Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966). Controller label: D50903.15 CR19100531.
• Recalling Firm/ Manufacturer: Sunrise Medical (US) LLC; 2842 N Business Park Ave; Fresno CA 93727-1328
• For Additional Information Contact: Mr. Devin I. McElroy; 559-294-2374
• Manufacturer Reason for Recall: Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond tested safe limits.
• FDA Determined Cause: Software Design Change
• Action: An URGENT: MEDICAL DEVICE RECALL letter was sent the firm's dealer. The dealer was instructed on February 4, 2020, to replace the controller unit for the device.
• Quantity in Commerce: 1
• Distribution: Distributed to US Consignee in MT.
• 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