Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall SurgiCount System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall SurgiCount System see related information
Date Initiated by Firm June 15, 2022
Create Date July 22, 2022
Recall Status1 Terminated 3 on April 05, 2024
Recall Number Z-1452-2022
Recall Event ID 90487
510(K)Number K060076  
Product Classification Counter, sponge, surgical - Product Code LWH
Product SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
Code Information UDI-DI (GTIN): 07613327543094; Serial Numbers: GK404E00828 GK404E00933 GK404E00959 GK404E01157 GK405E00282 GK405E00642 GK405E00671 GK405E00675 GK405E00693 GK405E00707 GK405E00757 GK405E00827 GK405E00857 GK405E00914 GK403E00537 GK404E00494 GK405E00176 GK405E00655 GK405E00723 GK403E00031 GK404E00638 GK404E00640 GK404E00700 GK404E00866 GK404E00887 GK404E00945 GK404E01113 GK404E01119 GK404E01121 GK404E01123 GK404E01170 GK404E01171 GK405E00602 GK49CE00058 GK404E00032 GK404E00034 GK404E00043 GK404E00262 GK404E00287 GK404E00287 211071 211115 211265   
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
Manufacturer Reason
for Recall		 When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Notification Software Update Notification letters dated June 2022 were sent to customers. Stryker Instruments will be updating the software on all SurgiCount+ Tablets (0794-001-010) distributed on or before May 1, 2022. Actions to be Taken 1. Immediately review this Software Update Notification. Advise OR staff, and all other personnel who may use this product, of the information in the Notification. 2. A local Stryker representative will schedule and perform the software update on each SurgiCount+ Tablet. A form, documenting the software update, will be completed by the Stryker Sales Representative, and a copy will be provided to your facility. 3. Please complete the enclosed Business Reply Form to confirm receipt of this notification. Return to Jordan.Greegor@stryker.com. We apologize for any inconvenience this action may cause your facility. Please forward a copy of this letter to any other personnel within your facility that you deem appropriate.
Quantity in Commerce 44 units
Distribution The products were distributed to the following US states: KS and ME.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LWH and Original Applicant = SURGICOUNT MEDICAL
-
-