Welch Allyn, Inc.
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard…
HScribe Holter Analysis System – version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24 in. monitor with 1920 x 1080 resolution; International\Canada power cord; No printer; Report Export + XML Orders (required for HL7 interface)
Who Else Makes It
Concentrated in Hebei (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | Shanghai | Specification developer | 6 |
Record
| Listed by | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | MLO |
| Device type | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2019-07-01 |
| Record revised | 2023-03-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2023-09-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | In distribution | |
| 901143 | Withdrawn | |
| 901143 | Withdrawn | |
| 901143 | Withdrawn | |
| 901143 | Withdrawn | |
| 901143 | Withdrawn | |
| 901143 | Withdrawn | |
| 901143 | Withdrawn | |
| 901143 | Withdrawn | |
| 901143 | Withdrawn | |
| 901143 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HScribe | Mortara Instrument, Inc. | 55 |
| Millennia Software | Braemar Manufacturing, LLC | 18 |
| Patient Cable | Global Instrumentation, LLC | 13 |
| Modality Manager | Mortara Instrument, Inc. | 10 |
| Norav 1200 Series PC-ECG | Norav Medical Inc. | 6 |
| Matrix Holter System | Global Instrumentation, LLC | 5 |
| GI Holter System | Global Instrumentation, LLC | 5 |
| Cardiospy ECG Holter System | Labtech Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság | 4 |
| WA Holter System | Global Instrumentation, LLC | 3 |
| Contec | Contec Medical Systems Co., Ltd. | 3 |
| Scribe | Mortara Instrument, Inc. | 2 |
| Pouch | Global Instrumentation, LLC | 2 |
Showing 12 of 33. All products under Electrocardiograph, Ambulatory, With Analysis Algorithm
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | UDI-DI | 2024-10-11 | Class II | Software design | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this coul | 599 units |
| Baxter Healthcare Corporation | UDI-DI | 2024-10-11 | Class II | Software design | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this coul | 1003 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.