Xhibit
Central STATION,96102,LOANER
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (5), 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 |
Record
| Listed by | Spacelabs Healthcare (Washington), Inc |
|---|---|
| FDA product code | MLD |
| Device type | Monitor, St Segment With Alarm |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| 510(k) | K122146 |
| Record published | 2016-10-04 |
| Record revised | 2020-05-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Storage | Storage environment humidity 5 to 95 % RH; Storage environment temperature -40 to 70 °C |
| Distribution end date | 2016-12-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 96102 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 48 |
| Vital Signs | Carefusion Finland 320 Oy | 23 |
| Lifee | CAF Medical Solutions Inc | 7 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 7 |
| Athena GTX Device Management Suite (Adms) Software | Athena GTX | 2 |
| Monitor, St Segment With Alarm | GE Healthcare Finland OY | 2 |
| Xhibit Telemetry Receiver | Spacelabs Healthcare (Washington), Inc | 1 |
| Contec | Contec Medical Systems Co., Ltd. | 1 |
| Advanced Patient Monitor | Advanced Instrumentations, Inc. | 1 |
| Comen | Shenzhen Comen Medical Instruments Co., Ltd. | 1 |
| Patient Monitor | Edan Instruments, Inc. | 1 |
| XTR | Spacelabs Healthcare (Washington), Inc | 1 |
Recalls Naming This Product
5 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 | 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 | 2016-02-26 | 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.