Change Healthcare Cardiology Hemo
8 catalogue numbers from 14.3.2, listed by Change Healthcare Canada Company, Canada, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
8catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (7), Shanghai (2), Jiangsu (1). 4 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 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Dongguan Ergotron Precision Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| 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 BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd | Shenzhen | Guangdong | Manufacturer | 7 |
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | Shanghai | Specification developer | 6 |
| Shenzhen Carewell Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Change Healthcare Canada Company, Canada |
|---|---|
| FDA product code | DQK |
| Device type | Computer, Diagnostic, Programmable |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1425 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K131497 |
| Record published | 2021-02-18 |
| Record revised | 2023-02-13 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14.3.2 | In distribution | |
| 15.1.4 | In distribution | |
| 14.3 | In distribution | |
| 15.0.1 | In distribution | |
| 15.1 | In distribution | |
| 15.1.2 | In distribution | |
| 15.0 | In distribution | |
| 15.1.1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EnSite™ | St. Jude Medical | 177 |
| Computer, Diagnostic, Programmable | St. Jude Medical | 57 |
| MediGuide™ | St. Jude Medical | 41 |
| AcQMap | Acutus Medical, Inc. | 38 |
| WorkMate Claris™ | St. Jude Medical | 35 |
| iLab Ultrasound Imaging System | Boston Scientific Corporation | 32 |
| Rhythmia™ Mapping System | Boston Scientific Corporation | 31 |
| Sentinel | Spacelabs Healthcare (Washington), Inc | 28 |
| Rhythmia HDx™ | Boston Scientific Corporation | 26 |
| EnSite Precision™ | St. Jude Medical | 23 |
| PathfinderSL | Spacelabs Healthcare (Washington), Inc | 22 |
| Labsystem™ PRO | Boston Scientific Corporation | 19 |
Showing 12 of 228. All products under Computer, Diagnostic, Programmable
Recalls Naming This Product
12 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Change Healthcare Canada Company | 510(k) number | 2025-05-22 | Class II | Software design | Due to complaints, software update may cause software to unexpectedly shutdown. | 29 systems | |
| Change Healthcare Canada Company | UDI-DI | 2025-05-22 | Class II | Software design | Due to complaints, software update may cause software to unexpectedly shutdown. | 4 systems | |
| A.L.I. Technologies, Inc. | 510(k) number | 2024-12-02 | Class II | Software design | Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s). | 1 unit | |
| A.L.I. Technologies, Inc. | 510(k) number | 2024-12-02 | Class II | Software design | Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s). | 204 units | |
| A.L.I. Technologies, Inc. | UDI-DI | 2024-12-02 | Class II | Software design | Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s). | 2 units | |
| Change Healthcare Canada Company | 510(k) number | 2024-08-21 | Class II | Use error | A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when | 221 systems | |
| Change Healthcare Canada Company | 510(k) number | 2024-08-21 | Class II | Use error | A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when | 35 systems | |
| Change Healthcare Israel Ltd. | 510(k) number | 2019-03-25 | Class II | Software Design Change | users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology Hemo” (Hemo). The discrepancy may also affect administered medicat | 125 devices | 2025-03-04 |
| Change Healthcare Israel Ltd. | 510(k) number | 2019-03-25 | Class II | Software Design Change | users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology Hemo” (Hemo). The discrepancy may also affect administered medicat | 1,383 devices | 2025-03-04 |
| Change Healthcare Israel Ltd. | 510(k) number | 2018-03-12 | Class II | Software Design Change | Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals. | 31 units | 2021-11-23 |
| Mckesson Information Solutions, LLC | 510(k) number | 2014-08-27 | Class II | Software design (manufacturing process) | Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations. | 272 devices | 2016-05-18 |
| Mckesson Information Solutions, LLC | 510(k) number | 2014-06-25 | Class II | Labeling design | McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes, and to identify in a timely manner whether a parameter box is out of calibration. McKess | 625 devices | 2017-10-26 |
Recalls
2 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 |
|---|---|---|---|---|
| 2024-08-21 | Class II | Use error | A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when | 3 systems |
| 2020-02-10 | Class II | Device Design | Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format | 51 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.