ClearanceBrief
Recall Z-0184-2023 ยท FPO Stretcher, Wheeled

Ferno-Washington Inc

FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model Number #0822484/0822483 Note: Transcend Stair Chair Powertraxx (Item #0731403/UDI-DI 00190790004064) not included in this action).

DateNov 4, 2022 (initiated Oct 7, 2022)
StatusOpen, Classified
ReasonBatteries could become unstable when not properly maintained and/or subjected to repeated drops, power washing directly into battery contacts or abuse, may result in a fire and/or injury
Root causeComponent design/selection
ActionFerno issued Urgent Product Correction on 10/7/22 via Certified Mail. Letter states reason for recall, health risk and action to take: Ferno will replace affected batteries with new batteries. Immediate Action. 1. Immediately check the serial number of your Ferno POWER X1 Ambulance Cot (see list within this notice) as well as the serial number on the bottom of any ENDURACharge 36V Li-Ion battery utilized with the cot. See How to Identify ENDURACharge Battery Date Code . 2. Check the serial number on the bottom of your ENDURACharge 36V Li-Ion battery to see if the battery is in the identified
Quantity1,922 units
DistributionNationwide Foreign: BRAZIL BRUNEI CHILE CHINA PERU POLAND PUERTO RICO TURKS&CACOS
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.