PlainRecalls

WELCH ALLYN, INC/MORTARA

9 recalls on record · Latest: Apr 28, 2021

FDA Devices Moderate Apr 28, 2021

Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product…

FDA Devices Moderate Apr 28, 2021

AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatri…

FDA Devices Moderate Dec 16, 2020

ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiogra…

FDA Devices Moderate May 6, 2020

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…

FDA Devices Moderate May 6, 2020

Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Con…

FDA Devices Moderate May 6, 2020

Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE I…

FDA Devices Moderate May 6, 2020

Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under the followin…

FDA Devices Moderate May 6, 2020

T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data …

FDA Devices Moderate May 6, 2020

Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.