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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

DateFirmReason
2026-08-21Midmark CorporationA performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21Midmark CorporationA performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21Midmark CorporationA performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21Midmark CorporationA performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-07-20GE Medical Systems Information Technologies IncSoftware 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
2026-07-20GE Medical Systems Information Technologies IncSoftware 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
2026-07-20GE Medical Systems Information Technologies IncSoftware 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
2026-07-20GE Medical Systems Information Technologies IncSoftware 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
2026-07-10GE Medical Systems Information Technologies IncPortrait Core Services Software version V1.2.0 Security Vulnerability
2026-01-30Covidien LLCDue 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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Data 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.