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U.S. Department of Health and Human Services

Class 2 Device Recall Quickie/Zippie Powered Wheelchair

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  Class 2 Device Recall Quickie/Zippie Powered Wheelchair see related information
Date Initiated by Firm February 13, 2020
Date Posted May 11, 2020
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = Sunrise Medical (US) LLC
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