Recall Z-1815-2020 ยท DPS Electrocardiograph
WELCH ALLYN, INC/MORTARA
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
| Date | Apr 29, 2020 (initiated Mar 18, 2020) |
| Status | Terminated |
| Reason | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. |
| Root cause | Device Design |
| Action | Welch Allyn notified customers on 2/19/2020 via "Voluntary Medical Device Correction Welch Allyn Patient Cables or Lead Sets". The recall letter identified the affected product and stated the reason for the recall. The firm also requested the distributors to immediately notify accounts if the product was further distributed. |
| Quantity | 78,521 units total |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160685 | Surveyor S4 Mobile Monitor Mortara Instrument, Inc., Aug 4, 2016 |