M Zn-Air Battery Pak
Brand(s)
Last updated
Summary
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.
Affected 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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ear, nose and throat
Companies
Advanced Bionics, LLC
28515 Westinghouse Place, Valencia, California, United States, 91355
Published by
Health Canada
Audience
General public
Recall class
Type II
Recall date
Identification number
RA-82035
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