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 SET AM15E 13-WIRE BANANA AHA GRAY, LEAD SET AM15E 13-WIRE BANANA IEC GRAY, RPLCE LEAD SET AM15E E2-E4 BANANA AHA GRAY, LEAD SET WAM 10 WIRE CLIPS AHA GRAY, LEAD SET WAM 10 WIRE CLIPS IEC GRAY, RPLCE LD SET WAM/AM12 LIMBS CLIP AHA GRY, RPLCE LD SET WAM/AM12 LIMBS CLIP IEC GRY, RPLCE LD SET WAM/AM12 V1-V3 CLIP AHA GRY, RPLCE LD SET WAM/AM12 C1-C3 CLIP IEC GRY, RPLCE LD SET WAM/AM12 V4-V6 CLIP AHA GRY, RPLCE LD SET WAM/AM12 C4-C6 CLIP IEC GRY, LEAD SET WAM/AM12 10-WIRE BANANA AHA GRY, LEAD SET WAM/AM12 10-WIRE BANANA IEC GRY, LD SET WAM/AM12 10 WRE SHORT AHA CLIP, LD SET WAM/AM12 10 WRE SHORT IEC CLIP.

Recall number

Z-1819-2020

Recalling firm

WELCH ALLYN, INC/MORTARA

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 SET AM15E 13-WIRE BANANA AHA GRAY, LEAD SET AM15E 13-WIRE BANANA IEC GRAY, RPLCE LEAD SET AM15E E2-E4 BANANA AHA GRAY, LEAD SET WAM 10 WIRE CLIPS AHA GRAY, LEAD SET WAM 10 WIRE CLIPS IEC GRAY, RPLCE LD SET WAM/AM12 LIMBS CLIP AHA GRY, RPLCE LD SET WAM/AM12 LIMBS CLIP IEC GRY, RPLCE LD SET WAM/AM12 V1-V3 CLIP AHA GRY, RPLCE LD SET WAM/AM12 C1-C3 CLIP IEC GRY, RPLCE LD SET WAM/AM12 V4-V6 CLIP AHA GRY, RPLCE LD SET WAM/AM12 C4-C6 CLIP IEC GRY, LEAD SET WAM/AM12 10-WIRE BANANA AHA GRY, LEAD SET WAM/AM12 10-WIRE BANANA IEC GRY, LD SET WAM/AM12 10 WRE SHORT AHA CLIP, LD SET WAM/AM12 10 WRE SHORT IEC CLIP.

Status

Terminated

Initiated

2020-03-18

Posted

2020-04-29

Terminated

2026-02-09

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.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

DPS

Firm FEI

2183461

Firm city

Milwaukee

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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