Reported May 6, 2020 · Terminated
Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA…
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?
- Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor
- under the following device namesPAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE IEC SNAP JSCREW. The Surveyor S12 patient monitor is designed for continuous monitoring in either stationary or portable applications
- Lot codes and dates
- Model Numbers
SUR12-XXX-XXXXXSUR19-XXX-XXXXX9293-033-529293-033-53
- 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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