Eclipse ProRecalls & reported problems
Spacelabs Healthcare (Washington), Inc · ECLIPSE PRO RECORDER,MULTILINGUAL · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names 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
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Nov 25, 2024Open, Classified
Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.
Z-0684-2025 · Root cause: Process control · FDA record ↗
Other Electrocardiograph, ambulatory (without analysis) devices
- Eclipse MiniSpacelabs Healthcare (Washington), Inc · Electrocardiograph, ambulatory (without analysis)1 recall0 reports
- PageWriter PageWriter TC20 CardiographPhilips Medical Systems Hsg · ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS)4 reports
- Holter Software Philips Holter SoftwarePhilips Medical Systems Hsg · ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS)1 report
- DigiTrak XT DigiTrak XT Holter RecorderPhilips Medical Systems Hsg · ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS)1 report
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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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