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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Z-1811-2020 - 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. 2 04/29/2020 WELCH ALLYN, INC/MORTARA
Z-1812-2020 - 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 10... 2 04/29/2020 WELCH ALLYN, INC/MORTARA
Z-1810-2020 - 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 Connex Cardio. Product Usage: A non-invasive pres... 2 04/29/2020 WELCH ALLYN, INC/MORTARA
Z-1817-2020 - 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 acquis... 2 04/29/2020 WELCH ALLYN, INC/MORTARA
Z-1818-2020 - Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system. 2 04/29/2020 WELCH ALLYN, INC/MORTARA
Z-1819-2020 - 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 GR... 2 04/29/2020 WELCH ALLYN, INC/MORTARA
Z-1815-2020 - 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 AH... 2 04/29/2020 WELCH ALLYN, INC/MORTARA
Z-1816-2020 - 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 IEC SNAP JSCREW. The Surveyor S12 patient monito... 2 04/29/2020 WELCH ALLYN, INC/MORTARA
Z-1813-2020 - 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 ... 2 04/29/2020 WELCH ALLYN, INC/MORTARA
Z-1814-2020 - 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 CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LE... 2 04/29/2020 WELCH ALLYN, INC/MORTARA
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