Spacelabs Healthcare, Ltd.
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Spacelabs Healthcare, Ltd. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-12-25FDA-DeviceClass IIEclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram.
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.
- 2024-12-25FDA-DeviceClass IIEclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
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.
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