Xhibit
DISPLAY,22" Capacitive Touch,black,anti-Glare
4manufacturers in China registered for this device type
4catalogue 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 | 2023-10-25 (version 21) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment temperature -10 to 60 °C; Storage environment atmospheric pressure 54 to 101 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Xhibit Central | In distribution | |
| Xhibit Central | In distribution | |
| Xhibit Central | In distribution | |
| Exhibit Central | In distribution |
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 |
| 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
Recalls Naming This Product
11 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 | 2026-06-04 | Class II | Unknown/Undetermined by firm | Due to off-the-shelf display port component that has audio/video failures | 6074 | |
| 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 | 2019-08-30 | Class II | Software Manufacturing/Software Deployment | The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition. | 2197 units | 2024-04-18 |
| 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 | 2016-10-18 | Class II | Software design | The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally. | 348 units (292 units in the US and 56 units outside the US) | 2017-04-03 |
| 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. | 798 units total (488 units in the US and 310 units outside U | 2017-03-13 |
| 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 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2016-02-26 | Class II | Software in the Use Environment | The firm has received one report of values for patient height and weight being switched when input at the Xhibit Central Station, Model 96102, causing a bedside monitor Body Surface Area (BSA) calculation to be in error. | total 1075 units (614 units in the US and 461 outside the US | 2016-10-24 |
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.