Recall Z-0549-2022— Philips North America Llc
Class II · Terminated
Class II FDA medical device recall by Philips North America Llc, initiated 2022-01-03, terminated 2024-04-11. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: eCareManager (eCM) Sentry Score software not approved for use.
- Recalling firm
- Philips North America Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-01-03
- Terminated
- 2024-04-11
- Firm location
- Cambridge, MA, United States
Product description
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
Reason for recall
eCareManager (eCM) Sentry Score software not approved for use
Data sourced from openFDA. This site is unofficial and independent of the FDA.