Recall Z-1819-2020

Welch Allyn, Inc/Mortara · initiated March 18, 2020

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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.

Codes / 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.

Reason for recall

Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

FDA-determined cause: Device Design

Action taken

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.

Details

Recall number
Z-1819-2020
Initiated
March 18, 2020
Posted by FDA
April 29, 2020
Terminated
February 9, 2026
Product code
DPS – Electrocardiograph
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.
Recalling firm
Welch Allyn, Inc/Mortara, Milwaukee, WI

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1810-2020 Class IILead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… 03/18/2020Terminated
Z-1811-2020 Class IIELI PC. The ELI PC Service automatically converts resting ECG recordings collected with…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… 03/18/2020Terminated
Z-1812-2020 Class IIH12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… 03/18/2020Terminated
Z-1813-2020 Class IIT12. Incorporates wireless electrocardiographic technology to achieve the real-time…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… 03/18/2020Terminated
Z-1814-2020 Class IIX12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… 03/18/2020Terminated
Z-1815-2020 Class IIS4 and patient cable for the S4 Wireless Telemeter with the following device names:…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… 03/18/2020Terminated
Z-1816-2020 Class IISurveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… 03/18/2020Terminated
Z-1817-2020 Class IIQ-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… 03/18/2020Terminated
Z-1818-2020 Class IIQ-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… 03/18/2020Terminated