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CARESCAPE TEMPERATURE

GE Medical Systems Information Technologies, Inc. · Model MKT101 · UDI-DI 00840682123952

MHX Prescription

510(k) clearances

33,126

Adverse events (1,928 deaths)

294

Recalls

118

Facilities

Description

CARESCAPE TEMPERATURE MKT101 MODULE

Recalls

Date	Firm	Reason
2026-09-16	Philips North America	Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity t
2026-09-08	Nihon Kohden America LLC	Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-07-31	Philips North America	Due to software malfunction, patient information system may freeze and become unresponsive.
2026-07-31	Philips North America	Due to software malfunction, patient information system may freeze and become unresponsive.

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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.