Class 2 Device Recall ENDURACharge 36V LiIon Battery

• Date Initiated by Firm: October 07, 2022
• Date Posted: November 04, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0184-2023
• Recall Event ID: 90957
• Product Classification: Stretcher, wheeled - Product Code FPO
• 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).
• Code Information: 36V Li-Ion Battery: 00190790005474 (UDI N/A; GTIN ONLY) ALL SERIAL NUMBERS MANUFACTURED DURING AND PRIOR TO YEAR 2021, WEEK 15 (e.g. Serial # 20300102115M594). Ferno POWER X1 Ambulance Cot Serial Numbers (SN): 18F003862 18F003863 18F003864 18F003865 18F003866 18F003867 18F003868 18F003869 18F003870 18F003871 18F003872 18F003873 18F003874 18F003875 18F003876 18F003877 18F003878 18F003879 18F003880 18F003881 18F003882 18F003883 18F003884 18F003893 18F003894 18F003895 18F003896 18F003897 18F003898 18F003899 18F003900 18F003921 18F003922 18F003923 18F003924 18F003925 18F003926 18F003927 18F003928 18F003930 18F003931 18F003932 18F003933 18F003934 18F003935 18F003936 18F003937 18F003940 18F003941 18F003942 18F003943 18F003944 18F003945 18F003946 18F003947 18F003950 18F003951 18F003952 18F003953 18F003954 18F003955 18F003956 18F003957 18F003958 18F003959 18F003960 18F003961 18F003962 18F003963 18F003964 18F003965 18F003966 18F003967 18F003968 18F003969 18F003970 18F003971 18F003972 18F003973 18F003974 18F003975 18F003976 18F003979 18F003980 18F003981 18F003982 18F003983 18F003984 18F003985 18F003986 18F003987 18F003988 18F003989 18F003990 18F003991 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• Recalling Firm/ Manufacturer: Ferno-Washington Inc; 70 Weil Way; Wilmington OH 45177-9371
• For Additional Information Contact: SAME; 937-283-2885
• Manufacturer 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
• FDA Determined Cause: Component design/selection
• Action: 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
• Quantity in Commerce: 1,922 units
• Distribution: Nationwide Foreign: BRAZIL BRUNEI CHILE CHINA PERU POLAND PUERTO RICO TURKS&CACOS
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.