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MR Patient Care Temperature Sensor (Esophageal / Rectal / Axillary, Direct Mode)
Philips Medizin Systeme Böblingen GmbH · Model Temperature Sensor (Esophageal/Rectal/Ax · UDI-DI 00884838111479
MWI
Prescription
10
510(k) clearances
2,174
Adverse events (46 deaths)
85
Recalls
174
Facilities
Description
Temperature sensor for Expression MRI patient monitors, capable of surface measurement or, with applied FlexTEMP Jacket, esophogeal/nasal/rectal body temperature.
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 | A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or acc |
| 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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