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.
Reported: May 6, 2020 Initiated: March 18, 2020 #Z-1814-2020
Product Description
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.
Reason for Recall
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Details
- Recalling Firm
- WELCH ALLYN, INC/MORTARA
- Units Affected
- 78,521 units total
- Distribution
- US nationwide distribution in the states of 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.
- Location
- Milwaukee, WI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by WELCH ALLYN, INC/MORTARA. Units affected: 78,521 units total.
Why was this product recalled? ▼
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2020. Severity: Moderate. Recall number: Z-1814-2020.
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