SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product
FDA device recall Z-1379-2016 · posted 2016-04-13 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- 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.
- Action taken
- 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
- Root cause
- Software design
- Status
- Terminated
- Product code
- LWH
- Quantity affected
- 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.
- Date initiated
- 2016-03-21
- Date posted
- 2016-04-13
- Date terminated
- 2016-09-06
- Location
- Portage, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGICOUNT SAFETY-SPONGE SYSTEM (K060076) | Surgicount Medical | 2006-03-14 |