FDA recall Z-1632-2020

Merits Holdings Co. dba Merits Health Products, Inc. · Class II · device

Product

Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.

Reason for recall

Pinion gear may disengage from track allowing lift to slip or jolt.

Distribution

US Nationwide distribution in the states of AZ, CA, CT, FL, GA, IN, MA, MD, ME, MO, NC, OH, PA, TX, and VA.

Key facts

Status
Terminated
Initiation date
2020-03-02
Report date
2020-04-08
Termination date
2023-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fort Myers, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1632-2020