Merge Hemo Link Assembly
Merge Hemo 77-00327-00 Link Assembly
10manufacturers in China registered for this device type
1catalogue number
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 | Merge Healthcare Solutions Inc. |
|---|---|
| FDA product code | DQK |
| Device type | Computer, Diagnostic, Programmable |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1425 |
| 510(k) | K082421 |
| Record published | 2019-06-27 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 77-00327-00 | 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
11 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Merge Healthcare Incorporated | 510(k) number | 2016-04-04 | Class II | Software design | In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation. | 361 sites potentially have the affected versions | 2019-08-05 |
| Merge Healthcare Incorporated | 510(k) number | 2016-04-04 | Class II | Software design | Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording. | 24 sites potentially have the affected versions | 2019-02-21 |
| Merge Healthcare Incorporated | 510(k) number | 2016-03-28 | Class II | Software design | There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC. | 242 sites potentially have the affected versions | 2019-06-28 |
| Merge Healthcare Incorporated | 510(k) number | 2016-03-10 | Class II | Software design | If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of the selected pressure waveform being provided by the PDM to the Link Assembly which provid | 555 PDM’s | 2020-03-06 |
| Merge Healthcare Incorporated | 510(k) number | 2015-10-26 | Class II | Process control | The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house. | 2 | 2016-07-22 |
| Merge Healthcare Incorporated | 510(k) number | 2015-05-31 | Class II | Nonconforming Material/Component | Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure. | 341 sites potentially have the affected product versions | 2020-03-13 |
| Merge Healthcare Incorporated | 510(k) number | 2015-03-30 | Class II | Unknown/Undetermined by firm | The units may display the alarm “sampling line clogged” after the flow zeroing procedure that is conducted automatically 1 hour after start up. This could result in the potential of a small bias added to the CO2 measurement and affect the | 23 sensors (PhaseIn Units) | 2017-05-05 |
| Merge Healthcare Incorporated | 510(k) number | 2015-01-21 | Class II | Software design | A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to another cath lab. | 451 | 2015-12-09 |
| Merge Healthcare Incorporated | 510(k) number | 2014-09-29 | Class II | Software design | It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient’s oxygen value. It is also possible that if using the pulse rate of the SpO2 finger clip to calculate the p | 52 | 2016-08-25 |
| Merge Healthcare Incorporated | 510(k) number | 2014-04-30 | Class II | Software design | The application may crash during the cath lab procedure. | 192 sites potentially have the affected software | 2019-12-23 |
| Merge Healthcare Incorporated | 510(k) number | 2012-07-02 | Class II | Software design | The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7 | 37 | 2017-06-26 |
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.