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Stryker Instruments Div. of Stryker Corporation recalls SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. P
Recalled April 20, 2016 · FDA recall Z-1379-2016 · Stryker Instruments Div. of Stryker
Hazard
The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). Also, the SurgiCounter scanner software version number is not appropriately displayed in the SC360 application during installation. · FDA Class II
Units
286
Sold at
US Nationwide Distribution in the states of AR, AZ, CA, CT, FL, GA, IN, LA, MD, MN, MO, MS, NJ, NM, NY, OH, SC, SD, TN, TX and UT.
Description
The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). Also, the SurgiCounter scanner software version number is not appropriately displayed in the SC360 application during installation.
Product
SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges, and towels used during surgical procedures.
Manufacturer(s)
Stryker Instruments Div. of Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →