Recall Z-1814-2020
Welch Allyn, Inc/Mortara · initiated March 18, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Model Numbers: X12PLUS-XXX-XXXXX, 9293-017-50, 9293-017-51, 9293-026-50, 9293-026-51, 9293-034-50
Reason for recall
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1814-2020
- Initiated
- March 18, 2020
- Posted by FDA
- April 29, 2020
- Terminated
- February 9, 2026
- Product code
- DPS – Electrocardiograph
- Quantity
- 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.
- Recalling firm
- Welch Allyn, Inc/Mortara, Milwaukee, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1810-2020 Class II | Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | 03/18/2020Terminated |
| Z-1811-2020 Class II | ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | 03/18/2020Terminated |
| Z-1812-2020 Class II | H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | 03/18/2020Terminated |
| Z-1813-2020 Class II | T12. Incorporates wireless electrocardiographic technology to achieve the real-time…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | 03/18/2020Terminated |
| Z-1815-2020 Class II | S4 and patient cable for the S4 Wireless Telemeter with the following device names:…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | 03/18/2020Terminated |
| Z-1816-2020 Class II | Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | 03/18/2020Terminated |
| Z-1817-2020 Class II | Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | 03/18/2020Terminated |
| Z-1818-2020 Class II | Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | 03/18/2020Terminated |
| Z-1819-2020 Class II | Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | 03/18/2020Terminated |