FDA-Device2022-02-09Class II
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. Model Number: 865325
Hazard
eCareManager (eCM) Sentry Score software not approved for use
Sold states
Worldwide distribution - US Nationwide and the country of Australia.
Affected count
36 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. Model Number: 865325
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0549-2022More Philips North America Llc recalls
- FDA-Device2026-07-01Philips Avalon FM20 Fetal Monitor recalled for speaker connector assembly defect
- FDA-Device2026-07-01Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
- FDA-Device2026-07-01Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.
- FDA-Device2026-06-17Philips DigitalDiagnost C90 Flex/Value/Chest/ER recalled for missing seismic stabilization kit
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