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Digistat Smart Central
ASCOM UMS SRL · Model SW000754 · UDI-DI 17350097870032
1
510(k) clearances
88
Adverse events
13
Recalls
25
Facilities
Description
Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party companies. Users receive, time-critical information from connected medical devices directly via their display devices as text, alarms or data. Digistat Smart Central allows users to be aware of their patients’ status and alarm conditions when they are away from the patient and associated medical devices.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-24 | ICU Medical, Inc. | Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use C |
| 2025-11-24 | ICU Medical, Inc. | For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate meth |
| 2025-06-20 | Baxter Healthcare Corporation | Certain Spectrum infusion pumps may have an incorrect version of software. |
| 2025-06-20 | Baxter Healthcare Corporation | Certain Spectrum infusion pumps may have an incorrect version of software. |
| 2025-05-02 | ICU Medical, Inc. | Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, p |
| 2025-02-18 | CareFusion 303, Inc. | Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). |
| 2025-02-18 | CareFusion 303, Inc. | Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). |
| 2022-09-08 | Fresenius Kabi USA, LLC | The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. Howe |
| 2022-04-22 | Ivenix, Inc. | Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm. |
| 2020-08-04 | CareFusion 303, Inc. | Infusion pump component defect may result in interruption of patient monitoring |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.