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U.S. Department of Health and Human Services

Class 2 Device Recall AC Powered Operating Room Table

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  Class 2 Device Recall AC Powered Operating Room Table see related information
Date Initiated by Firm January 29, 2021
Create Date March 24, 2021
Recall Status1 Open3, Classified
Recall Number Z-1297-2021
Recall Event ID 87331
Product Classification Table, operating-room, ac-powered - Product Code FQO
Product S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502
Components that are affected within the S-Series Finished Good Model Number
o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD
o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD
o P40553 - ASM, MFR HANDLE REPAIR, LIFTING, S-SERIES, STANDARD
o P40554 - ASM, MFR HANDLE REPAIR, FIXED, S-SERIES, STANDARD
o P46269 - ASSY, MFR CONTROLLER UPGRADE, STANDARD
Code Information Serial Numbers: 2258046 2863490  
Recalling Firm/
Manufacturer		 Stryker Communications
571 Silveron Blvd
Flower Mound TX 75028
For Additional Information Contact Saijal Naik
469-470-4321
Manufacturer Reason
for Recall		 The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Capacitive Touch Controls on the MFRs rotational electrical magnetic brakes may disengage when an electrocautery device is in use.
FDA Determined
Cause 2		 Under Investigation by firm
Action An Urgent Customer Notification Letter was mailed (certified) to the affected consignees on 01/29/2021. Customers will be notified by letter and a Stryker Representative will visit each account for product inspection and replacement. If customers notice any issues prior to inspection, customers should discontinue use and call Technical Support immediately at (866) 841-5663.
Quantity in Commerce 1,393 units
Distribution Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and WY. The country of Canada.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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