Z-1297-2021 Class II Ongoing
FDA device recall Z-1297-2021 was initiated by Stryker Communications on January 29, 2021 and is designated Class II. 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 whe… The recall status is ongoing. Affected quantity: 1,393 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 31, 2021
- Initiation Date
- January 29, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,393 units
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.
Distribution Pattern
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.
Code Information
Serial Numbers: 2258046 2863490