Manufacturer

Welch Allyn Inc Mortara

16 recalls in our database name Welch Allyn Inc Mortara as the manufacturing or recalling firm.

What the numbers show

Total: 16
Critical: 0
Severe: 0
Most recent: 2021-10-13

Of the 16 recalls from Welch Allyn Inc Mortara we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–16 of 16

HighFDA (Devices)·Z-0011-2022·2021-10-13
ELI 280 Resting Electrocardiographs Recalled Due to Device Malfunction
Welch Allyn Inc Mortara is recalling ELI 280 Resting Electrocardiographs due to device malfunction under specific operator workflows. The recall affects 14,630 units distributed nationwide and internationally.
Product
ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1484-2021·2021-04-28
Welch Allyn Surveyor Bedside Patient Monitor Recalled for Safety Standard Non-Compliance
Welch Allyn is recalling 213 Surveyor S12/S19 Bedside Patient Monitors because they do not meet IEC 60601-2-27 safety requirements as labeled.
Product
Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1482-2021·2021-04-28
Welch Allyn ELI 280 Electrocardiograph Recalled for Safety Standard Non-Compliance
Welch Allyn is recalling 99 ELI 280 Electrocardiographs because they do not meet IEC 60601-2-27 safety requirements as labeled.
Product
ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1483-2021·2021-04-28
Welch Allyn ELI 380 Electrocardiograph Recalled for IEC 60601-2-27 Non-Compliance
Welch Allyn Inc Mortara is recalling 27 ELI 380 Electrocardiographs because they do not meet IEC 60601-2-27 requirements as labeled.
Product
ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1485-2021·2021-04-28
Welch Allyn AM12M Acquisition Module Recalled for IEC 60601-2-27 Non-Compliance
Welch Allyn Inc Mortara is recalling 746 AM12M Acquisition Modules because they do not meet IEC 60601-2-27 requirements as labeled.
Product
AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0553-2021·2020-12-16
Welch Allyn ELI 380 Electrocardiograph Recalled for Wireless Disconnection
Welch Allyn is recalling 1,009 ELI 380 Electrocardiographs because the internal radio can disconnect from the wireless access point.
Product
ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1817-2020·2020-05-06
Welch Allyn Q-Stress and XScribe Diagnostic Devices Recalled for Safety Standard Deficiency
Welch Allyn is recalling Q-Stress and XScribe diagnostic devices because they may not meet specific defibrillation withstand safety requirements.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1810-2020·2020-05-06
Welch Allyn Electrocardiographs Recalled for Defibrillation Safety Non-Compliance
Welch Allyn is recalling 78,521 lead diagnostic electrocardiographs because they may not meet defibrillation withstand requirements.
Product
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 Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and pri
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1816-2020·2020-05-06
Welch Allyn Surveyor S12 and S19 Patient Monitors Recalled for Defibrillation Safety
Welch Allyn is recalling 78,521 Surveyor S12 and S19 bedside monitors and patient cables because they may not meet defibrillation withstand safety requirements.
Product
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 IEC SNAP JSCREW. The Surveyor S12 patient monitor is designed for continuous monitoring in either stationary or portable applica
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1819-2020·2020-05-06
Welch Allyn ECG Lead Sets Recalled for Defibrillation Safety Non-Compliance
Welch Allyn is recalling 78,521 ECG lead sets because they may not meet defibrillation withstand safety requirements.
Product
Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under the following device names: LEAD SET WAM 10 WIRE BANANA AHA GRAY, LEAD SET WAM 10 WIRE BANANA IEC GRAY, RPLCE LD SET WAM/AM12 LIMBS BANA AHA G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1812-2020·2020-05-06
Welch Allyn H12+ Holter Recorders Recalled for Defibrillation Safety Non-Compliance
Welch Allyn is recalling H12+ Holter Recorders and patient cables because they may not meet defibrillation withstand requirements.
Product
H12+ and patient cable for the H12+ Holter Recorders 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. The 24-hour H12+ recorder uses a single AA alkali
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1811-2020·2020-05-06
Welch Allyn ELI PC Service Recalled for Defibrillation Safety Non-Compliance
Welch Allyn is recalling ELI PC Service software because it may not meet defibrillation withstand safety requirements for medical electrical equipment.
Product
ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1813-2020·2020-05-06
Welch Allyn T12 Wireless ECG Devices Recalled for Defibrillation Safety
Welch Allyn is recalling T12 wireless ECG devices because they may not meet defibrillation withstand safety requirements.
Product
T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1815-2020·2020-05-06
Welch Allyn S4 Wireless Telemeter Recall for Defibrillation Safety
Welch Allyn is recalling S4 Wireless Telemeters and patient cables because they may not meet defibrillation withstand safety standards.
Product
S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AHA GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS IEC GRAY. The S4 mobile monitor prov
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1814-2020·2020-05-06
Welch Allyn X12+ Telemeter and Patient Cable Recall for Defibrillation Safety
Welch Allyn is recalling X12+ Telemeters and patient cables because they may not meet defibrillation withstand requirements.
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1818-2020·2020-05-06
Welch Allyn Q-Tel RMS System Recalled for Defibrillation Safety Non-Compliance
Welch Allyn is recalling 78,521 Q-Tel RMS systems because they may not meet defibrillation withstand safety requirements.
Product
Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.
Category
Medical Device
Distribution
Distributed nationwide