Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Pilot

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Pilot see related information
Date Initiated by Firm March 02, 2020
Create Date April 01, 2020
Recall Status1 Terminated 3 on September 18, 2023
Recall Number Z-1632-2020
Recall Event ID 85154
Product Classification Accessories, wheelchair - Product Code KNO
Product Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
Code Information Model: E60424YLMUB; SN: MU180600588; (01) 04714379292589 (11)190604 (21) MU190600025.
Recalling Firm/
Manufacturer		 Merits Holdings Co. dba Merits Health Products, Inc.
4245 Evans Ave
Fort Myers FL 33901-9311
For Additional Information Contact Dwight Crostreet
239-772-0579
Manufacturer Reason
for Recall		 Pinion gear may disengage from track allowing lift to slip or jolt.
FDA Determined
Cause 2		 Device Design
Action Merits Health Products notified customers on 03/17/2020 via "Medical Device Field Correction E604 Pilot Navigator" letter. The letter identified the affected product and requested the customers to complete the form.
Quantity in Commerce 82 units.
Distribution US Nationwide distribution in the states of AZ, CA, CT, FL, GA, IN, MA, MD, ME, MO, NC, OH, PA, TX, and VA.
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.
-
-