Recall Z-1297-2021— Stryker Communications
Class II · Ongoing
Class II FDA medical device recall by Stryker Communications, initiated 2021-01-29. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- Stryker Communications
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-01-29
- Firm location
- Flower Mound, TX, United States
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.