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MR Patient Care Temperature Sensor Jacket

Philips Medizin Systeme Böblingen GmbH · Model Temperature Sensor Jacket · UDI-DI 10884838111407

MWI Prescription

510(k) clearances

2,174

Adverse events (46 deaths)

Recalls

174

Facilities

Description

Disposable Flex Temp Jacket is designed for use with the FlexTEMP System, Sensor. The FlexTEMP Jacket must be used with the FlexTEMP Sensor while measuring Body temperature. This Sensor should also be used for surface temperature to reduce the occurrence of infection

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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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.