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MRI Patient Monitor TeslaDUO
MIPM Mammendorfer Institut für Physik und Medizin GmbH · Model TeslaDUO · UDI-DI 04255629200508
MWI
Prescription
1
510(k) clearances
2,065
Adverse events (45 deaths)
85
Recalls
174
Facilities
Description
The MRI Patient Monitor TeslaDUO is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-21 | Midmark Corporation | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| 2026-08-21 | Midmark Corporation | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| 2026-08-21 | Midmark Corporation | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| 2026-08-21 | Midmark Corporation | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and |
| 2026-07-10 | GE Medical Systems Information Technologies Inc | Portrait Core Services Software version V1.2.0 Security Vulnerability |
| 2026-01-30 | Covidien LLC | Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring s |
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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.
