Welch Allyn S4 Telemeter (Welch Allyn) – Defibrillation Risk (2020)
Medical device may not meet defibrillation withstand requirements.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 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.
Brand
WELCH ALLYN, INC/MORTARA
Lot Codes / Batch Numbers
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.
Products Sold
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.
WELCH ALLYN, INC/MORTARA is recalling S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF due to Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Recommended Action
Per FDA guidance
Welch Allyn notified customers on 2/19/2020 via "Voluntary Medical Device Correction Welch Allyn Patient Cables or Lead Sets". The recall letter identified the affected product and stated the reason for the recall. The firm also requested the distributors to immediately notify accounts if the product was further distributed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026