CanadaM Zn‑Air Battery Pak (models CI‑5501‑110, ‑120, ‑130, ‑140, ‑150, ‑190, ‑240, ‑250, ‑260, ‑270 and ‑280; all lots) is affected. The non‑tamperproof battery door allows battery access without a tool and does not meet IEC 60601‑1‑11:2015 clause 8.5.2, creating a potential safety risk. Follow the manufacturer’s instructions to remove and dispose of the non‑tamperproof battery door and ask for replacements with tamperproof battery doors.
What's being recalled
Companies: Advanced Bionics, LLC, 28515 Westinghouse Place, Valencia, California, United States, 91355.
How to identify it
Affected products: M Zn-Air Battery Pak; Lot or serial number: All lots.; Model or catalogue number: CI-5501-150
Affected products: M Zn-Air Battery Pak; Lot or serial number: All lots.; Model or catalogue number: CI-5501-260
Affected products: M Zn-Air Battery Pak; Lot or serial number: All lots.; Model or catalogue number: CI-5501-280
Affected products: M Zn-Air Battery Pak; Lot or serial number: All lots.; Model or catalogue number: CI-5501-110
Affected products: M Zn-Air Battery Pak; Lot or serial number: All lots.; Model or catalogue number: CI-5501-190
Affected products: M Zn-Air Battery Pak; Lot or serial number: All lots.; Model or catalogue number: CI-5501-250
Affected products: M Zn-Air Battery Pak; Lot or serial number: All lots.; Model or catalogue number: CI-5501-120
Affected products: M Zn-Air Battery Pak; Lot or serial number: All lots.; Model or catalogue number: CI-5501-240
Affected products: M Zn-Air Battery Pak; Lot or serial number: All lots.; Model or catalogue number: CI-5501-270
Affected products: M Zn-Air Battery Pak; Lot or serial number: All lots.; Model or catalogue number: CI-5501-130
Affected products: M Zn-Air Battery Pak; Lot or serial number: All lots.; Model or catalogue number: CI-5501-140
The hazard
The non‑tamperproof battery door in the M Zn‑Air Battery Pak (CI‑5501) does not meet IEC 60601‑1‑11:2015 clause 8.5.2 because it allows battery access without a tool, creating potential safety risk. No injuries are reported, but the recall instructs customers to dispose of the affected door per local guidelines.
What to do
Follow manufacturer's instructions on removing non-tamperproof battery door and dispose of it. Ask for replacements with tamperproof battery doors.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States