Recall Z-1819-2020 ยท DPS Electrocardiograph
WELCH ALLYN, INC/MORTARA
Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under the following device names: LEAD SET WAM 10 WIRE BANANA AHA GRAY, LEAD SET WAM 10 WIRE BANANA IEC GRAY, RPLCE LD SET WAM/AM12 LIMBS BANA AHA GRY, RPLCE LD SET WAM/AM12 LIMBS BANA IEC GRY, RPLCE LD SET WAM/AM12 V1-V3 BANA AHA GRY, RPLCE LD SET WAM/AM12 C1-C3 BANA
| 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
This recall record lists no 510(k) number.