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
Reported: February 9, 2022 Initiated: January 3, 2022 #Z-0549-2022
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
Details
- Recalling Firm
- Philips North America Llc
- Units Affected
- 36 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Australia.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Philips North America Llc. Units affected: 36 units.
Why was this product recalled? ▼
eCareManager (eCM) Sentry Score software not approved for use
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 9, 2022. Severity: Moderate. Recall number: Z-0549-2022.
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