Spacelabs Healthcare
Miscellaneous power supply, supplies or other accessories
9manufacturers in China registered for this device type
20catalogue 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) | K121480 |
| Record published | 2016-11-21 |
| Record revised | 2024-05-03 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 0 °C; Storage environment humidity 0 to 0 % RH |
| Distribution end date | 2020-11-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Elance | In distribution | ||
| SUPPLY | In distribution | ||
| Elance | In distribution | ||
| 91388 | In distribution | ||
| Elance | In distribution | ||
| SUPPLY | In distribution | ||
| SUPPLY | In distribution | ||
| SUPPLY | In distribution | ||
| 93300 | In distribution | ||
| SUPPLY | 3 | Withdrawn | |
| SUPPLY | 3 | Withdrawn | |
| SUPPLY | 3 | Withdrawn | |
| 96280 | Withdrawn | ||
| 96280 | Withdrawn | ||
| SUPPLY | 3 | Withdrawn | |
| SUPPLY | 5 | Withdrawn | |
| SUPPLY | 3 | Withdrawn | |
| SUPPLY | Withdrawn | ||
| 94267 | Withdrawn | ||
| 93300 | 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
18 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 | 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 |
| 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 | 2014-08-26 | Class II | Environmental control | The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. The firm performed a retrospective analysis of all recalls since 2011 and discovered 222 additional s | 82 units distributed in US and 140 units distributed outside | 2015-06-26 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2014-07-02 | Class II | Software design | The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-2014 because additional s | 8 units | 2014-10-16 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2013-12-19 | Class II | Software design | The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (transmitter) display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sens | 1057 units (988 in the US and 69 outside of the US). | 2014-06-12 |
| 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 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2011-07-08 | Not classified | Device Design | The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. | total 2812 units distributed worldwide | 2012-05-23 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2011-03-24 | Not classified | Other | The circuit that supplies backup power to the modules in the Medical Patient Monitor, Model 91387, is not working. If there is a power interruption, the three-minute backup may not be operational and customers may lose any changes they hav | 4470 units total (1894 units in US and 2579 units internatio | 2012-02-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability.
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