TeleRehab Software File Manager
SCOTTCARE CORPORATION, THE · Model TeleRehab Software File Manager · UDI-DI 00856298006244
Description
The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow monitoring and recording of electrocardiograph (ECG) rhythm strips and related information for patients undergoing an exercise therapy program. Patients are monitored by medical telemetry exercise monitoring equipment. This feature allows patients to comply with exercise prescriptions while exercising at a medical/rehabilitation facility near their home, or by returning to the primary medical facility to participate in an in-house cardiopulmonary rehabilitation program. VersaCare includes a Program Management module that prints a variety of reports.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-20 | Midmark Corporation | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. |
| 2024-07-19 | Biointellisense Inc. | Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification. |
| 2021-01-08 | Nihon Kohden America Inc | Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. |
| 2020-05-21 | Vitalconnect Inc. | A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should have triggered a notification to the care team, but no notification was f |
| 2017-05-15 | Boston Scientific Corporation | The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing. |
| 2017-03-02 | Philips Visicu | eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological device |
| 2016-03-10 | Philips Visicu | The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the |
| 2012-02-24 | BRAEMAR, INC. | Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. Th |
| 2011-05-02 | BRAEMAR, INC. | Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor. The event did not result i |
| 2007-12-13 | Lifesync Corporation | LifeSync Wireless ECG System - Intermittent failure when using LS-202 and LS-232 LeadWear in conjunction with LS-41245 and LS-41285 Adaptors. The out of box failure manifests as a |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs