Home / Recalls / WELCH ALLYN, INC/MORTARA / Z-1817-2020

Z-1817-2020 Class II Terminated

Recalled by WELCH ALLYN, INC/MORTARA — Milwaukee, WI

Recall Details

Product Type
Devices
Report Date
May 6, 2020
Initiation Date
March 18, 2020
Termination Date
February 9, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
78,521 units total

Product Description

Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules.

Reason for Recall

Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

Distribution Pattern

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.

Code Information

Model Numbers: QS-6XX-XXXXX, XSCRIBE-5XX-XXXXX, XSCRIBE-6XX-XXXXX.

Other recalls by WELCH ALLYN, INC/MORTARA

  • Z-0553-2021 Class II — ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, m (November 11, 2020)
  • Z-1814-2020 Class II — X12+ and patient cable for the X12+ Telemeter with the following device name: PA (March 18, 2020)
  • Z-1810-2020 Class II — Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI (March 18, 2020)
  • Z-1819-2020 Class II — Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG (March 18, 2020)
  • Z-1816-2020 Class II — Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the fol (March 18, 2020)
  • Z-1813-2020 Class II — T12. Incorporates wireless electrocardiographic technology to achieve the real-t (March 18, 2020)
  • Z-1812-2020 Class II — H12+ and patient cable for the H12+ Holter Recorders with the following device n (March 18, 2020)
  • Z-1811-2020 Class II — ELI PC. The ELI PC Service automatically converts resting ECG recordings collect (March 18, 2020)
  • Z-1815-2020 Class II — S4 and patient cable for the S4 Wireless Telemeter with the following device nam (March 18, 2020)
  • Z-1818-2020 Class II — Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilita (March 18, 2020)