Derived label

Device software or design

Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge Stryker handpiece battery packs only. The battery charger has the optional functionality to track device usage data. Usage data is accumulated by Stryker and reports are able to be provided to the customer. For powered surgical instruments.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: software correction to address the issue
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Stryker Instruments Div. of Stryker Corporation