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 IEC GRY, RPLCE LD SET WAM/AM12 V4-V6 BANA AHA GRY, RPLCE LD SET WAM/AM12 C4-C6 BANA IEC GRY, LEAD S Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 IEC GRY, RPLCE LD SET WAM/AM12 V4-V6 BANA AHA GRY, RPLCE LD SET WAM/AM12 C4-C6 BANA IEC GRY, LEAD S
Brand
WELCH ALLYN, INC/MORTARA
Lot Codes / Batch Numbers
Model Numbers: 9293-046-60 - 9293-047-71, 9293-017-50 - 9293-017-51, 9293-026-50 - 9293-026-51, 9293-061-50 - 9293-061-53, 9293-033-52 - 9293-033-53 and 9293-034-50.
Products Sold
Model Numbers: 9293-046-60 - 9293-047-71; 9293-017-50 - 9293-017-51; 9293-026-50 - 9293-026-51; 9293-061-50 - 9293-061-53; 9293-033-52 - 9293-033-53 and 9293-034-50.
WELCH ALLYN, INC/MORTARA is recalling Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for vario due to Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026