AMC
Advantage Medical Electronics, LLC · Model AC-6X924/CCL · UDI-DI 00849593000000
DRG
Prescription
10
510(k) clearances
1,714
Adverse events (73 deaths)
12
Recalls
126
Facilities
Description
Disp Cl Ft Poly Telepouch,24" Top String,Clip,Velcro Lock
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 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.