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Recall Observatory FDA recall evidence

Device product

Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA

Z-0332-2022

November 12, 2021

Class II

Product summary

Firm
Covidien Llc
Event
Event 89024
Status
Ongoing
Classification
Class II
Quantity
2 units OUS
Official record key
device-enforcement:Z-0332-2022

Official wording

Reason: Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit

Code information: Serial Numbers: MCSB006939, MCSB006947 GTIN: 10884521592896

Distribution pattern: Brazil

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit