Recall Z-1297-2021 ยท FQO Table, Operating-Room, Ac-Powered
Stryker Communications
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
| Date | Jan 29, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.