The Recall Desk
HighFDA (Devices)·Z-1815-2020·Announced 2020-05-06

Welch Allyn S4 Wireless Telemeter Recall for Defibrillation Safety

Welch Allyn is recalling S4 Wireless Telemeters and patient cables because they may not meet defibrillation withstand safety standards.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device that may not meet safety standards for defibrillation withstand, posing a risk of harm to patients during defibrillation procedures, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Welch Allyn, Inc/Mortara is recalling the S4 Wireless Telemeter and associated patient cables. The specific devices affected include the S4 mobile monitor and patient cables with model numbers S4-Q-ASX-XXX, S4-Q-AXX-XXX, S4-P-A, 9293-061-50, 9293-061-51, 9293-061-52, and 9293-061-53. The S4 mobile monitor is designed to acquire and transmit simultaneous ECG and SpO2 data to a Surveyor Central Station monitoring system while allowing patients to be ambulatory within a WiFi network range.

The recall was initiated because the impacted products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. This standard ensures that medical electrical equipment can withstand the effects of defibrillation without causing harm to the patient or operator.

A total of 78,521 units were distributed nationwide in the United States, including the District of Columbia, Puerto Rico, and Ontario, Canada. The affected states include 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. Healthcare facilities and users should contact Welch Allyn for instructions on how to address the non-compliance with the defibrillation withstand requirements.

The recalled product

Product
S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 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 prov
Manufacturer
WELCH ALLYN, INC/MORTARA
Category
Medical Device — Cardiac Monitoring
Hazard
Affected units
78,521

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • 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.

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 10 recalled by WELCH ALLYN, INC/MORTARA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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