Xprezzon
Medical Grade Display, Xprezzon AND Qube
9manufacturers in China registered for this device type
6catalogue 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) | K112962 |
| Record published | 2017-03-10 |
| Record revised | 2023-10-26 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 95 % RH; Storage environment temperature -40 to 75 °C |
| Distribution end date | 2024-12-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Xprezzon Monitor | In distribution | |
| Xprezzon Monitor | In distribution | |
| Xprezzon Display | In distribution | |
| 91393 | Withdrawn | |
| Xprezzon | Withdrawn | |
| Xprezzon Monitor | Withdrawn |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
7 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 | 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 | 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.