Reported May 6, 2020 · Terminated
Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various…
Welch Allyn, Inc/mortara
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: WELCH ALLYN, INC/MORTARA · 7865 N 86th St · Milwaukee, WI · 53224-3431
Is this the product you have?
- 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 GRAYLEAD SET WAM 10 WIRE BANANA IEC GRAYRPLCE LD SET WAM/AM12 LIMBS BANA AHA GRYRPLCE LD SET WAM/AM12 LIMBS BANA IEC GRYRPLCE LD SET WAM/AM12 V1-V3 BANA AHA GRYRPLCE LD SET WAM/AM12 C1-C3 BANA IEC GRYRPLCE LD SET WAM/AM12 V4-V6 BANA AHA GRYRPLCE LD SET WAM/AM12 C4-C6 BANA IEC GRYLEAD SET AM15E 13-WIRE BANANA AHA GRAYLEAD SET AM15E 13-WIRE BANANA IEC GRAYRPLCE LEAD SET AM15E E2-E4 BANANA AHA GRAYLEAD SET WAM 10 WIRE CLIPS AHA GRAYLEAD SET WAM 10 WIRE CLIPS IEC GRAYRPLCE LD SET WAM/AM12 LIMBS CLIP AHA GRYRPLCE LD SET WAM/AM12 LIMBS CLIP IEC GRYRPLCE LD SET WAM/AM12 V1-V3 CLIP AHA GRYRPLCE LD SET WAM/AM12 C1-C3 CLIP IEC GRYRPLCE LD SET WAM/AM12 V4-V6 CLIP AHA GRYRPLCE LD SET WAM/AM12 C4-C6 CLIP IEC GRYLEAD SET WAM/AM12 10-WIRE BANANA AHA GRYLEAD SET WAM/AM12 10-WIRE BANANA IEC GRYLD SET WAM/AM12 10 WRE SHORT AHA CLIPLD SET WAM/AM12 10 WRE SHORT IEC CLIP
- Lot codes and dates
- Model Numbers
9293-046-60 - 9293-047-719293-017-50 - 9293-017-519293-026-50 - 9293-026-519293-061-50 - 9293-061-539293-033-52 - 9293-033-53 and 9293-034-50
- Model Numbers
- Amount recalled
- 78,521 units total
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was recalled
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Welch Allyn, Inc/mortara recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.