FDA Device recall Z-1379-2016
SurgiCounter scanner, part of the SurgiCount Safety-Sponge System
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of SurgiCounter scanner, part of the SurgiCount Safety-Sponge System by Stryker Instruments Div, citing 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).….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1379-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-21 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | Model Number(s): 0694-097-000 0694-097-001 Units individually serialized, SN numbers included in recall Letter.…Model Number(s): 0694-097-000 0694-097-001 Units individually serialized, SN numbers included in recall Letter. Units distributed 11/1/2015-12/17/2015 Stryker Product Number: 0694097000 Serial# 1525901643 1526602693 1526603463 1526708353 1531400083 1531400453 1531400823 1525901653 1526602713 1526603473 1526708393 1531400093 1531400463 1531400833 1525901663 1526602723 1526603483 1526708403 1531400103 1531400473 1531400843 1525901673 1526602733 1526603493 1526708413 1531400113 1531400483 1531400853 1525901683 1526602743 1526603503 1526708423 1531400123 1531400493 1531400863 1525901693 1526602753 1526603513 1526708443 1531400133 1531400503 1531400873 1525901703 1526602863 1526603523 1526708463 1531400143 1531400513 1531400883 1525901713 1526602873 1526603533 1526708473 1531400153 1531400523 1531400893 1525901723 1526602883 1526603543 1526708493 1531400163 153140 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1379-2016%22
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