FDA Recall
Terminated
Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
Recall: Z-1632-2020
·
Initiated March 2, 2020
Recall
- Recall Number
- Z-1632-2020
- Event Number
- 85154
- Firm
- Merits Holdings Co. dba Merits Health Products, Inc.
- FEI Number
- 1000221992
- Product Code
- KNO
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- March 2, 2020
- Terminated
- September 18, 2023
- Address
- 4245 Evans Ave, Fort Myers, FL, 33901-9311
Description
Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
Reason
Pinion gear may disengage from track allowing lift to slip or jolt.
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.
Distribution
US Nationwide distribution in the states of AZ, CA, CT, FL, GA, IN, MA, MD, ME, MO, NC, OH, PA, TX, and VA.
Quantity
82 units.