Reported May 6, 2020 · Terminated

S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS 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

S4 and patient cable for the S4 Wireless Telemeter
with the following device namesCABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AHA GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS IEC GRAY. The S4 mobile monitor provides a means to acquire and transmit simultaneous ECG and SpO2 data to a Surveyor Central Station monitoring system while allowing the patient to be ambulatory within the range of the WiFi network

Lot codes and dates: Model Numbers
S4-Q-ASX-XXX
S4-Q-AXX-XXX
S4-P-A
9293-061-50
9293-061-51
9293-061-52
9293-061-53
Amount recalled: 78,521 units total

The agency filed one notice per product. You are reading one of them; the other 9 are below.

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.

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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