Xper Flex Cardio Physiomonitoring System
24 catalogue numbers from Xper FC2010 REV E Russian Exchange, listed by Philips DS North America LLC, United States, under Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms). 17 manufacturers in China are registered for this product code.
17manufacturers in China registered for this device type
24catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (10), Beijing (2), Jiangsu (1). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Armorlink SH Corp | Shanghai | Shanghai | Contract manufacturer | 2 |
| Tontec Precision Plastics Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| 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 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
Showing 12 of 17. All 17 manufacturers in China registered for Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Record
| Listed by | Philips DS North America LLC, United States |
|---|---|
| FDA product code | MWI |
| Device type | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2300 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2019-09-11 |
| Record revised | 2025-06-11 (version 12) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment atmospheric pressure 70 to 103 KiloPascal; Storage environment humidity 15 to 90 % RH |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Xper FC2010 REV E Russian Exchange | In distribution | |
| Xper FC2010 Rev E EXCHANGE | In distribution | |
| Xper Flex Cardio 2010 Rev E | In distribution | |
| Xper Flex Cardio FC2010 REV E Russian | In distribution | |
| FC2010 | Withdrawn | |
| Xper Flex Cardio FC2020 REV E | Withdrawn | |
| FC 2020 | Withdrawn | |
| FC 2010 | Withdrawn | |
| Xper Flex Cardio 2020 Rev D Exchange | Withdrawn | |
| Xper Flex Cardio 2020 Rev E Exchange | Withdrawn | |
| FC 2010 | Withdrawn | |
| Xper Flex Cardio FC2020 REV C | Withdrawn | |
| FC 2010 | Withdrawn | |
| Xper Flex Cardio 2010 Rev D Russia | Withdrawn | |
| FC2010 | Withdrawn | |
| Xper Flex Cardio 2010 Rev D | Withdrawn | |
| Xper FC2010 Rev D EXCHANGE | Withdrawn | |
| FC 2010 | Withdrawn | |
| Xper Flex Cardio FC2010 REV C | Withdrawn | |
| Xper FC2010 Rev D Russia Exchange | Withdrawn | |
| Xper Flex Cardio FC2010 REV C Russian | Withdrawn | |
| FC 2020 | Withdrawn | |
| FC2020 | Withdrawn | |
| Xper Flex Cardio 2020 Rev D | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 501 |
| SmartLinx Vitals Plus | Philips North America LLC | 174 |
| Norav 1200 Series PC-ECG | Norav Medical Inc. | 154 |
| Capsule Vitals Plus | Philips North America LLC | 64 |
| Iradimed | Iradimed Corporation | 59 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | GE Medical Systems Information Technologies, Inc. | 44 |
| Medrad® Veris™ 8600 Vital Signs Monitor | Bayer Medical Care Inc. | 26 |
| Wvsm Wireless Vital Signs Monitor | Athena GTX | 23 |
| 740 Select | ZOE Medical, Inc. | 20 |
| Wvsm Pro, Wireless Vital Signs Monitor Professional | Athena GTX | 20 |
| BioStamp nPoint™ | Medidata Solutions, Inc. | 19 |
| BioStamp nPoint™ | Mc10, Inc. | 18 |
Showing 12 of 314. All products under Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Philips North America LLC | UDI-DI | 2021-03-29 | Class II | Software design | Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters; patient weight is rounded to the nearest whole kilogram;Xper | 9208 units WW | |
| Invivo Corporation | UDI-DI | 2018-09-24 | Class II | Software Design Change | The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure wav | 76 units | |
| Invivo Corporation | UDI-DI | 2018-03-14 | Class II | Software design | The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate. Because ventricular pressure monitoring is only performed in the cardiac catheterization procedure room using the FC2 | 4375 units | 2021-04-30 |
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.