M Zn-Air Battery Pak

Product M Zn-Air Battery Pak Issue Medical devices - Performance 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 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.

RA-82035