eCareManager
Telehealth Center Product License
4manufacturers in China registered for this device type
8catalogue numbers in this listing
5510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
Record
| Listed by | Visicu, Inc., United States |
|---|---|
| FDA product code | MSX |
| Device type | System, Network And Communication, Physiological Monitors |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2300 |
| 510(k) | K211046 |
| Record published | 2022-11-10 |
| Record revised | 2023-10-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2022-08-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4.6 | In distribution | |
| 4.3 | In distribution | |
| 4.4 | In distribution | |
| 4.5 | In distribution | |
| 4.7 | In distribution | |
| 4.1 | Withdrawn | |
| 4.2 | Withdrawn | |
| 4.0 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Messenger | Spok Inc. | 9 |
| Engage Medical Device Alarm Notification System (Emdan) | Stryker GmbH | 8 |
| BeneVision Central Monitoring System | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 7 |
| Xhibit | Spacelabs Healthcare (Washington), Inc | 4 |
| IntelliVue XDS Software | Philips Medizin Systeme Böblingen GmbH | 4 |
| Ascom | Ascom Sweden AB | 3 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 3 |
| Patient SafetyNet Console | Masimo Corporation | 3 |
| System, Network And Communication, Physiological Monitors | Philips Medical Systems Hsg | 3 |
| RescueNet 12-Lead | Zoll Medical Corporation | 2 |
| Telemetry Transmitter | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 2 |
| Current Health Wearable Monnitoring System | Current Health Ltd | 2 |
Showing 12 of 165. All products under System, Network And Communication, Physiological Monitors
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211046 | 2022-06-03 |
| K171322 | 2017-08-03 |
| K153156 | 2016-09-30 |
| K012171 | 2001-07-24 |
| K001972 | 2000-10-27 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Philips North America LLC | UDI-DI | 2022-01-03 | Class II | Under Investigation by firm | eCareManager (eCM) Sentry Score software not approved for use | 36 units | 2024-04-11 |
| Visicu, Inc. | 510(k) number | 2015-03-27 | Class II | Software design | A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously selected medication is replaced with what | 43 | 2016-09-23 |
| Visicu, Inc. | 510(k) number | 2012-02-22 | Not classified | Software change control | Three versions of software for the eCareManager failed to display anticoagulants on the medications screen. The problem arose due to an unexpected change in the National Drug Data File. | 12 | 2012-07-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.