Cardiopulonary Corp.
Catalogue number Surveillance Monitoring System Software, listed by Philips North America LLC, United States, under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms). 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
1catalogue number
40recalls on this code
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 | Philips North America LLC, United States |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2017-04-11 |
| Record revised | 2026-01-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2026-01-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Surveillance Monitoring System Software | Withdrawn |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
37 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-07-31 | Not classified | Software design | Due to software malfunction, patient information system may freeze and become unresponsive. | 312 units | |
| 2026-07-31 | Not classified | Software design | Due to software malfunction, patient information system may freeze and become unresponsive. | 7359 Units | |
| 2026-06-05 | Class II | Software design | Potential for device reset to default “NEW_DEVICE” state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system. | 909 units | |
| 2025-12-22 | Class II | Software Design Change | A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system. | 146 units (41 US, 105 OUS) | |
| 2025-12-12 | Class II | Software design | It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly. | 13,470 Units | |
| 2025-10-31 | Class II | Use error | Potential issue where the IntelliVue monitors did not alarm. | 1,913,441 units | |
| 2025-10-31 | Class II | Use error | Potential issue where the IntelliVue monitors did not alarm. | 1,913,441 units | |
| 2025-10-31 | Class II | Use error | Potential issue where the IntelliVue monitors did not alarm. | 1,913,441 units | |
| 2025-10-31 | Class II | Use error | Potential issue where the IntelliVue monitors did not alarm. | 1,913,441 units | |
| 2025-01-15 | Class II | Software design | Potential failure to alarm for “No Device Data” INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board. | 98 units | |
| 2025-01-15 | Class II | Software design | Potential failure to alarm for “No Device Data” INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board. | 74 units | |
| 2025-01-15 | Class II | Software design | Potential failure to alarm for “No Device Data” INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board. | 2,230 units | |
| 2025-01-15 | Class II | Software design | Potential failure to alarm for “No Device Data” INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board. | 45 units | |
| 2025-01-15 | Class II | Software design | Potential failure to alarm for “No Device Data” INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board. | 28 units | |
| 2024-11-20 | Class II | Under Investigation by firm | The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another Access Point potentially causing the client device to appear to drop out from th | 4,811 units | |
| 2024-08-30 | Class II | Nonconforming Material/Component | During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect th | 545 devices | |
| 2024-06-28 | Class II | Software design | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements o | 18 units | |
| 2024-06-28 | Class II | Software design | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements o | 4 units | |
| 2024-06-28 | Class II | Software design | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements o | 9 units US | |
| 2024-06-28 | Class II | Software design | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements o | 49 units | |
| 2024-04-19 | Class II | Software design | Event Catalog information does not save when copied and transferred from one unit to another. | 358 units (US: 45; OUS: 313) | |
| 2024-03-22 | Class II | Component design/selection | Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the lack of power. may lead to the delay in the detect | 12,936 units | |
| 2024-02-28 | Class II | Under Investigation by firm | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode. | 257,183 Units | |
| 2024-02-15 | Class II | Device Design | If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of a change in a patient condition which pr | 555 units | |
| 2023-11-28 | Class II | Software design | Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition. | 41 US; 773 OUS | |
| 2023-11-28 | Class II | Software design | Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition. | 254 US; 37 OUS | |
| 2023-08-17 | Class II | Under Investigation by firm | Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to restart and continue central patient monitoring. Potent | 960 units | |
| 2023-06-14 | Class II | Process control | Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full | 153 units OUS | |
| 2021-03-23 | Class II | Software design | Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of heart rate meter for pediatric mode-In pediatric mode, when the input signal rate is over 300 bpm, the indicated rate of the affected products w | 31773 units | 2023-09-28 |
| 2020-06-30 | Class II | Process control | Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monitor if the grounding instructions were not followed, and may also cause the monito | 28 | 2024-01-25 |
| 2020-06-30 | Class II | Process control | Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monitor if the grounding instructions were not followed, and may also cause the monito | 28 | 2024-01-25 |
| 2020-06-25 | Class II | Software design | The device may experience an interruption of gas measurement due to a firmware issue, ceasing measurement and display of gas levels and generating one or more technical or INOP alarms. | 3075 | |
| 2020-03-05 | Class II | Software design | The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed when it is used with a Philips Patient Information Center iX Release C.02.xx or C.03.01. If this occurs, t | 21,672 | 2021-02-11 |
| 2020-03-05 | Class II | Software design | The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed when it is used with a Philips Patient Information Center iX Release C.02.xx or C.03.01. If this occurs, t | 81,626 | 2021-02-11 |
| 2019-08-23 | Class II | Process control | Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations | 1790 units | 2024-01-03 |
| 2019-04-29 | Class III | Software design | Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX using a LAN driver may be recorded in the patients cha | 12,391 | 2024-11-22 |
| 2019-04-19 | Class II | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. | 3177 | |
| 2019-04-19 | Class II | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. | 21857 | |
| 2019-04-19 | Class II | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. | 12719 | |
| 2019-04-19 | Class II | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. | 1397 |
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.