TruSignal SpO2
Trusignal SPO2 TS-F2-GE
9manufacturers in China registered for this device type
6catalogue numbers in this listing
15510(k) clearances naming this product code
10recalls 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 | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K031781 |
| Record published | 2016-06-16 |
| Record revised | 2025-08-26 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment humidity 5 to 95 % RH; Storage environment temperature -40 to 60 °C |
| Distribution end date | 2026-02-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TS-F4-GE | In distribution | |
| TS-E2-GE | In distribution | |
| TS-E4-GE | In distribution | |
| TS-E4-N | Withdrawn | |
| TS-F2-GE | Withdrawn | |
| TS-F4-N | Withdrawn |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 |
|---|---|
| K260656 | 2026-09-01 |
| K260343 | 2026-08-28 |
| K223531 | 2023-04-06 |
| K213363 | 2022-04-13 |
| K213336 | 2022-04-13 |
| K213181 | 2022-04-13 |
| K191323 | 2020-01-29 |
| K191249 | 2020-01-24 |
| K191149 | 2020-01-21 |
| K143676 | 2015-07-31 |
| K132533 | 2013-12-04 |
| K131414 | 2013-08-28 |
| K131223 | 2013-08-28 |
| K102239 | 2010-10-18 |
| K092680 | 2009-09-23 |
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 |
|---|---|---|---|---|---|---|
| GE Healthcare Finland OY | UDI-DI | 2023-05-19 | Class I | Device Design | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. | 512 devices |
| GE Healthcare Finland OY | UDI-DI | 2023-05-19 | Class I | Device Design | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. | 2707 units |
| GE Healthcare Finland OY | UDI-DI | 2023-05-19 | Class I | Device Design | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. | 708 devices |
Recalls
10 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-09-26 | Class II | Component change control | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and pot | 5935 |
| 2025-09-26 | Class II | Component change control | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and pot | 2857 |
| 2025-09-26 | Class II | Component change control | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and pot | 3271 |
| 2025-09-26 | Class II | Component change control | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and pot | 7408 |
| 2025-09-26 | Class II | Component change control | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and pot | 5990 |
| 2024-04-05 | Class II | Software design | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU tim | 25268 units |
| 2024-04-05 | Class II | Software design | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU tim | 4649 units |
| 2024-04-05 | Class II | Software design | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU tim | 9267 units |
| 2024-04-05 | Class II | Software design | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU tim | 54800 units |
| 2024-04-05 | Class II | Software design | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU tim | 547 units |
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.