Z-1819-2020Class II

Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various...

Name: Z-1819-2020 Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various...
Creator: Welch Allyn, Inc/mortara
Published: 2020-03-18
License: https://open.fda.gov/license/

Mortara Instrument, Inc. / initiated 2020-03-18 / Terminated / root cause: design

FDA source

WELCH ALLYN, INC/MORTARA began a recall of Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under the following device... on 2020-03-18. FDA classified it as Class II and gives the reason as "Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1819-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-18
Posted: 2020-04-29
Terminated: 2026-02-09
Recalling firm: Mortara Instrument, Inc.
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.
Product code: DPS Electrocardiograph
Reason for recall: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1819-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1810-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1811-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1812-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1813-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1814-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1815-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1816-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1817-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1818-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1819-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29

Product code DPS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)