Apr

2016

Cl II Stryker SurgiCounter” scanner

Company: Stryker Instruments Div. of Stryker Corporation
Date of Enforcement Report 4/20/2016
Class lI:

PRODUCT

SurgiCounter” scanner 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.
Recall Number Z-1379-2016

REASON
The affected SurgiCounter scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, there is a potential for the affected SurgiCounter scanner to display an error message (code=2). Additionally, the SurgiCounter scanner software version number is not appropriately displayed in the SC360 application during installation.

RECALLING FIRM/MANUFACTURER
Stryker Instruments Div. of Stryker Corporation, Portage, MI on 3/1/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
286

DISTRIBUTION
Nationwide

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Stryker SurgiCounter” scanner

Amy Sellers

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