XScribe Cardiopulmonary Kit 41000-030-64Recalls & reported problems
Mortara Instrument, Inc. · Cardiopulmonary accessory kit cleared with XScribe · Class 2
All models of XScribe Cardiopulmonary Kit (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier, 2 still open.
4 other recalls cover devices cleared under the same FDA submission (K152944); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Dec 8, 2023Class IIOpen, Classified
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
Z-0707-2024 · Root cause: Software design · Recall details · FDA record ↗
- Dec 8, 2023Class IIOpen, Classified
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
Z-0706-2024 · Root cause: Software design · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K152944. One submission often covers many models, so check the product and lot details in each record.
- Z-0321-2025 · Oct 11, 2024 · Open, ClassifiedHillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
- Z-0325-2025 · Oct 11, 2024 · Open, ClassifiedHillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
- Z-0705-2024 · Dec 8, 2023 · Open, ClassifiedQ-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6
- Z-1817-2020 · Mar 18, 2020 · TerminatedQ-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 wire
Other Electrocardiograph devices
- ELI 380 ELI380-DCS11Mortara Instrument, Inc. · Electrocardiograph1 recall1 death70 reports
- Cardiac Workstation Cardiac Workstation 7000Philips Medizin Systeme Böblingen GmbH · Electrocardiograph2 recalls17 reports
- Q-Stress QSERV-6AA-XXXXBMortara Instrument, Inc. · Electrocardiograph2 recalls1 report
- Cardiac Workstation Cardiac Workstation 5000Philips Medizin Systeme Böblingen GmbH · Electrocardiograph2 recalls1 report
- MAC VU360GE Medical Systems Information Technologies, Inc. · Electrocardiograph2 recalls1 report
- XScribe Cardiopulmonary Kit 41000-030-60Mortara Instrument, Inc. · Electrocardiograph2 recalls0 reports
- Welch Allyn, Inc. 901049Welch Allyn, Inc. · ELECTROCARDIOGRAPH2 recalls0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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