Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
S4 and patient cable for the S4 Wireless Telemeter with Recalled by WELCH ALLYN, INC/MORTARA Due to Impacted Welch Allyn products may not meet the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact WELCH ALLYN, INC/MORTARA directly.
Affected Products
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.
Quantity: 78,521 units total
Why Was This Recalled?
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About WELCH ALLYN, INC/MORTARA
WELCH ALLYN, INC/MORTARA has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report