FDA recall Z-0184-2023

Ferno-Washington Inc · Class II · device

Product

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).

Reason for recall

Batteries 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

Distribution

Nationwide Foreign: BRAZIL BRUNEI CHILE CHINA PERU POLAND PUERTO RICO TURKS&CACOS

Key facts

Status: Ongoing
Initiation date: 2022-10-07
Report date: 2022-11-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Wilmington, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0184-2023