FDA-Device2015-05-13Class III
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 powe
Stryker Instruments Div. of Stryker Corporation
Hazard
The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as designed. The firm is initiating a software correction to address the issue.
Sold states
US Nationwide in the states of AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MD, MI, MO, MS, MT, NC, NH, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI and the foreign country of: Canada
Affected count
223 chargers
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1587-2015Don't want to check this manually?
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