Reported May 6, 2020 · Terminated
X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL…
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?
- X12+ and patient cable for the X12+ Telemeter
- with the following device name
PAT CBL 10WIRE LEADFORM AHA SNAPPAT CBL 10WIRE LEADFORM IEC SNAPPAT CBL 10WIRE LEADFORM XL AHA SNAPPAT CBL 10WIRE LEADFORM XL IEC SNAPPAT CBL 4WIRE AHA SNAP HC
- Lot codes and dates
- Model Numbers
X12PLUS-XXX-XXXXX9293-017-509293-017-519293-026-509293-026-519293-034-50
- 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.
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