Xhibit
DISPLAY,21.5",CAPACITIVE Touch,black, Anti-Glare
9manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). 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 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| General Meditech, Inc. | Shenzhen | Guangdong | Complaint-file establishment | 3 |
Record
| Listed by | Spacelabs Healthcare (Washington), Inc |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| 510(k) | K141156 |
| Record published | 2019-02-25 |
| Record revised | 2024-05-08 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 54 to 101 KiloPascal; Storage environment temperature 0 to 50 °C |
| Distribution end date | 2024-06-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Xhibit Central | In distribution | |
| Exhibit Central | In distribution | |
| Xhibit XC4 | In distribution | |
| Xhibit Central | In distribution | |
| Exhibit Central | 21.5″ | In distribution |
| Xhibit Central | In distribution | |
| Xhibit Central | In distribution | |
| 96102 | Withdrawn | |
| 91393 | 61 cm UOM length 24 inches UOM length | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 326 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 266 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden Corp. | 205 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden America, Inc. | 139 |
| Surveyor Central | Mortara Instrument, Inc. | 71 |
| Tempus Pro | Remote Diagnostic Technologies Ltd. | 44 |
| Surveyor S12 | Mortara Instrument, Inc. | 38 |
| Ultraview | Spacelabs Healthcare (Washington), Inc | 29 |
| Surveyor S19 | Mortara Instrument, Inc. | 26 |
| Vital Signs™ | AirLife Finland Oy | 23 |
| Patient Monitor | Edan Instruments, Inc. | 22 |
| Telemetry Accessories | Philips Medizin Systeme Böblingen GmbH | 21 |
Showing 12 of 589. All products under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Recalls Naming This Product
17 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 | 2025-09-05 | Class II | Device Design | Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient’s safety by interfering with the operation of another electronically s | 8179 | |
| Spacelabs Healthcare Ltd. | 510(k) number | 2025-09-05 | Class II | Device Design | Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient’s safety by interfering with the operation of another electronically s | 820 | |
| Spacelabs Healthcare Ltd. | 510(k) number | 2025-09-05 | Class II | Device Design | Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient’s safety by interfering with the operation of another electronically s | 16898 | |
| 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 | 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 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2015-01-28 | Class II | Device Design | Spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are recalled because the firm has received multiple reports of XPREZZON monitors failing to boot up or returning to factory default configuration settings following power on or re | total 1578 units (702 units in the US and 876 outside US) | 2015-12-30 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2012-10-05 | Class II | Vendor change control | Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation. | 169 units distributed (98 in US and 71 Internationally) | 2013-03-25 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2012-06-12 | Class II | Software design | There were reports that a certain combination of key presses will cause the module to disconnect from the Xprezzon bedside monitor, model 91393, and the patient parameters will drop from the display. The parameters return after power cyclin | 21 units | 2012-11-28 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2012-05-22 | Not classified | Device Design | The screw used to connect the external power supply to the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, may damage an internal capacitor. The damage may result in an inability of the monitor to power on, power off, or involunta | 1898 monitors (Domestic: 1188) (International: 710) | 2013-05-07 |
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.