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Welch Allyn Inc Mortara Recalls
16 recalls on record · May 6, 2020 to October 13, 2021 · Medical Devices
Recalls by year
20
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 13, 2021Medical DevicesFDA
Welch Allyn Inc Mortara recalls ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: EL
Hazard: The devices malfunction under specific operator workflows.
April 28, 2021Medical DevicesFDA
Welch Allyn Inc Mortara recalls AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated
Hazard: Devices do not meet IEC 60601-2-27 requirements as labeled.
April 28, 2021Medical DevicesFDA
Welch Allyn Inc Mortara recalls Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM1
Hazard: Devices do not meet IEC 60601-2-27 requirements as labeled.
April 28, 2021Medical DevicesFDA
Welch Allyn Inc Mortara recalls ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version
Hazard: Devices do not meet IEC 60601-2-27 requirements as labeled.
April 28, 2021Medical DevicesFDA
Welch Allyn Inc Mortara recalls ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version
Hazard: Devices do not meet IEC 60601-2-27 requirements as labeled.
December 16, 2020Medical DevicesFDA
WELCH ALLYN, INC/MORTARA recalls ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph.
Hazard: The radio within the device can become disassociated with the wireless access point.
May 6, 2020Medical DevicesFDA
WELCH ALLYN, INC/MORTARA recalls Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiograp
Hazard: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
May 6, 2020Medical DevicesFDA
WELCH ALLYN, INC/MORTARA recalls Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system
Hazard: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
May 6, 2020Medical DevicesFDA
WELCH ALLYN, INC/MORTARA recalls Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, S
Hazard: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
May 6, 2020Medical DevicesFDA
WELCH ALLYN, INC/MORTARA recalls Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA
Hazard: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
May 6, 2020Medical DevicesFDA
WELCH ALLYN, INC/MORTARA recalls S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA G
Hazard: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
May 6, 2020Medical DevicesFDA
WELCH ALLYN, INC/MORTARA recalls X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL
Hazard: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
May 6, 2020Medical DevicesFDA
WELCH ALLYN, INC/MORTARA recalls T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of s
Hazard: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
May 6, 2020Medical DevicesFDA
WELCH ALLYN, INC/MORTARA recalls H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, P
Hazard: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
May 6, 2020Medical DevicesFDA
WELCH ALLYN, INC/MORTARA recalls ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpl
Hazard: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
May 6, 2020Medical DevicesFDA
WELCH ALLYN, INC/MORTARA recalls Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 2
Hazard: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.