Z-1815-2020 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
S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AHA GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS IEC GRAY. The S4 mobile monitor provides a means to acquire and transmit simultaneous ECG and SpO2 data to a Surveyor Central Station monitoring system while allowing the patient to be ambulatory within the range of the WiFi network.
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: S4-Q-ASX-XXX, S4-Q-AXX-XXX, S4-P-A, 9293-061-50, 9293-061-51, 9293-061-52, 9293-061-53.