Recall Z-1379-2016 ยท LWH Counter, Sponge, Surgical
Stryker Instruments Div. of Stryker Corporation
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.
| Date | Apr 13, 2016 (initiated Mar 21, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| 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 kellyjo.davis@stryker.com |
| Quantity | 286 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060076 | SURGICOUNT SAFETY-SPONGE SYSTEM Surgicount Medical, Mar 14, 2006 |