Spacelabs Healthcare
KIT, Multi-Band, WO/PS, Plen, ACT Ant,adc
4manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | Spacelabs Healthcare (Washington), Inc |
|---|---|
| FDA product code | MSX |
| Device type | System, Network And Communication, Physiological Monitors |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2300 |
| 510(k) | K141156 |
| Record published | 2017-01-06 |
| Record revised | 2022-11-28 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 0 to 0 °C; Storage environment humidity 0 to 0 % RH |
| Distribution end date | 2019-02-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 96280 | In distribution | |
| 96280 | Withdrawn | |
| 96280 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Messenger | Spok Inc. | 9 |
| eCareManager | Visicu, Inc. | 8 |
| 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 |
| 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
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Spacelabs Healthcare Ltd. | 510(k) number | 2024-11-25 | Class II | Labeling design | Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occu | 2265 | |
| Spacelabs Healthcare Ltd. | 510(k) number | 2024-11-25 | Class II | Software change control | Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occu | 434 | |
| Spacelabs Healthcare Ltd. | 510(k) number | 2022-05-31 | Class II | Software Design Change | Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not | 529 | |
| Spacelabs Healthcare Ltd. | 510(k) number | 2018-01-17 | Class II | Under Investigation by firm | Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring. | 12 systems | 2018-11-29 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2016-08-25 | Class II | Software design | The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital. | 316 XTR units total (248 units in the US and 68 units outsid | 2017-03-13 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2016-03-28 | Class II | Other | Reports of an abnormally high frequency of squelch events on Xhibit Telemetry Receivers (XTR), which is indicative of the loss of the telemetry data signal. In some cases, the Xhibit Central Monitor was also reported to display an Xhibit Of | 217 units of XTRs and 531 units of PCBAs (164 XTRs and 425 P | 2016-12-19 |
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.