Z-1814-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- March 18, 2020
- Termination Date
- February 9, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 78,521 units total
Product Description
X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP, PAT CBL 4WIRE AHA SNAP HC.
Reason for Recall
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Distribution Pattern
US nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, PR, RI, SC, SD, TN,UT, VA, VT, WA, WI, WV and WY.
Code Information
Model Numbers: X12PLUS-XXX-XXXXX, 9293-017-50, 9293-017-51, 9293-026-50, 9293-026-51, 9293-034-50