FDA-Device2022-07-27Class II
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
Stryker Instruments Div. of Stryker Corporation
Hazard
When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.
Sold states
The products were distributed to the following US states: KS and ME.
Affected count
44 units
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1452-2022Don't want to check this manually?
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