FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model Number #0822484/082248

FDA device recall Z-0184-2023 · posted 2022-11-04 · Open, Classified

Recall details

Recalling firm

Ferno-Washington Inc

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

Action taken

Ferno 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 date code range. If it is not, no further action is required and the battery may remain in service provided it does not have a compromised seal, damaged case, cracks, deformities, other visual damage or is hot to the touch. Regardless of date code, if you identify a battery that has a compromised seal, damaged case, cracks, deformities, other visual damage or is hot to the touch, the battery should be immediately removed from service and moved outside your building. 3. ALL ENDURACHARGE 36V LI-ION BATTERIES MANUFACTURED WITHIN THE ABOVE REFERENCED DATE CODE RANGE MUST BE REPLACED. If you have a battery that is in the identified date code range, immediately visually inspect the battery. If you identify a battery that has a compromised seal, damaged case, cracks, deformities, other visual damage or is hot to the touch, the battery should be immediately removed from service and moved outside your building. As stated in the battery manual, A damaged battery can cause fire and/or injury. Inspect the battery before each use. If damaged, remove from service, recycle per the regulations in your country, and replace. If you have a battery that is in the identified date code range and it does not display any wear or damage and is operating as intended, the following actions should be immediately taken if use is continued while awaiting a replacement battery: " Do not leave the battery

Root cause

Component design/selection

Status

Open, Classified

Product code

FPO

Quantity affected

1,922 units

Distribution

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

Date initiated

2022-10-07

Date posted

2022-11-04

Location

Wilmington, OH