ClearanceBrief
Recall Z-1632-2020 ยท KNO Accessories, Wheelchair

Merits Holdings Co. dba Merits Health Products, Inc.

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

DateMar 2, 2020
StatusTerminated
ReasonPinion gear may disengage from track allowing lift to slip or jolt.
Root causeDevice Design
ActionMerits 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.
Quantity82 units.
DistributionUS Nationwide distribution in the states of AZ, CA, CT, FL, GA, IN, MA, MD, ME, MO, NC, OH, PA, TX, and VA.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.