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.
FDA Recall Z-1379-2016 · Posted 2016-04-13
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Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeLWH
Date Initiated2016-03-21
Date Terminated2016-09-06
Product Quantity286
Reason for Recall
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.
Firm Action
Stryker sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letters dated March 21, 2016 to affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments:
Kelly Jo Davis
269-389-2921
[email protected]
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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