Recall MonitorHealth Products
M Zn-Air Battery Pak
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Ear, nose and throat
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.
Audience: General public
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| M Zn-Air Battery Pak | All lots. | CI-5501-150 |
| M Zn-Air Battery Pak | All lots. | CI-5501-260 |
| M Zn-Air Battery Pak | All lots. | CI-5501-280 |
| M Zn-Air Battery Pak | All lots. | CI-5501-110 |
| M Zn-Air Battery Pak | All lots. | CI-5501-190 |
| M Zn-Air Battery Pak | All lots. | CI-5501-250 |
| M Zn-Air Battery Pak | All lots. | CI-5501-120 |
| M Zn-Air Battery Pak | All lots. | CI-5501-240 |
| M Zn-Air Battery Pak | All lots. | CI-5501-270 |
| M Zn-Air Battery Pak | All lots. | CI-5501-130 |
| M Zn-Air Battery Pak | All lots. | CI-5501-140 |
Issue
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.