Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
X12+ and patient cable for the X12+ Telemeter with the 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
X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP, PAT CBL 4WIRE AHA SNAP HC.
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