Patient Information Center Ix
9 catalogue numbers from Patient Information Center iX 4.8, listed by Philips Medizin Systeme Böblingen GmbH, Germany, 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
9catalogue numbers in this listing
5510(k) clearances naming this product 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 Medizin Systeme Böblingen GmbH, Germany |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Record published | 2026-07-13 |
| Record revised | 2025-12-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2023-08-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Patient Information Center iX 4.8 | In distribution | |
| 4.4 | In distribution | |
| 4.2 | In distribution | |
| Patient Information Center iX | In distribution | |
| Patient Information Center iX | In distribution | |
| 4.5 | In distribution | |
| 4.7 | In distribution | |
| 4.6 | In distribution | |
| Patient Information Center iX | Withdrawn |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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251702 | 2025-11-10 |
| K250453 | 2025-09-02 |
| K242962 | 2025-05-05 |
| K221348 | 2023-02-03 |
| K211900 | 2022-03-04 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Philips North America LLC | UDI-DI | 2026-07-31 | Not classified | Software design | Due to software malfunction, patient information system may freeze and become unresponsive. | 7359 Units |
| Philips North America LLC | UDI-DI | 2026-07-31 | Not classified | Software design | Due to software malfunction, patient information system may freeze and become unresponsive. | 312 units |
| Philips North America LLC | UDI-DI | 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) |
| Philips North America LLC | UDI-DI | 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 |
| Philips North America LLC | UDI-DI | 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 |
| Philips North America LLC | UDI-DI | 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 |
| Philips North America LLC | UDI-DI | 2023-04-19 | Class II | Software design | During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address w | 591 devices |
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.