Z-0549-2022Class II

eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version...

Name: Z-0549-2022 eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version...
Creator: Philips North America Llc
Published: 2022-01-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2022-01-03 / Terminated / root cause: software

FDA source

Philips North America Llc began a recall of 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... on 2022-01-03. FDA classified it as Class II and gives the reason as "eCareManager (eCM) Sentry Score software not approved for use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0549-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-03
Posted: 2022-02-01
Terminated: 2024-04-11
Recalling firm: Philips North America LLC
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
Product code: MSX System, Network And Communication, Physiological Monitors
Reason for recall: eCareManager (eCM) Sentry Score software not approved for use
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: Philips issued Urgent Medical Device Correction letter eCareManager (eCM) Sentry Score to customers via email on 03-Jan-2022. FedEx letters delivered 05-Jan-2022 or 06-Jan-2022. Letter states reason for recall, health risk and action to take: 1 Stop using Sentry Score immediately 2 Share this communication with eCareManager users/Clinicians/ Health Care providers within your organization as soon as possible. 3 Complete the Urgent Medical Device Correction Response form and return to Philips via any one of the below methods: - Email - [email protected] - FedEx Please use the return envelope. The correction will be accomplished in 2 steps Step 1: Philips will contact you to schedule approximately 10 minutes of down time for eCareManager as soon as possible, at your convenience. During this downtime the configuration will be updated, so that Sentry Score will not be accessible. This means you will no longer be able to use Sentry Score. All other functions of eCareManager will continue to work as intended. Step 2: Philips will be creating a software update package, which will be installed at your site for the version of eCareManager software that is running on your system. Sentry Score will be removed from the software as well as any reference to Sentry Score on any of the screens via the software update package. All appropriate documents (clinical user guide etc.) will be provided to you as part of this update. As soon as the software update packages are available, you will be contacted by Philips to update the system with the software update package to remove Sentry Score. If you need any further information or support concerning this issue, please contact your local Philips representative: Email: [email protected]
Quantity in commerce: 36 units
Distribution: Worldwide distribution - US Nationwide and the country of Australia.
Product codes and lots: Software Version/ UDI 4.2.1 (01)00884838087453(10)4.2.1 4.3.2* (01)00884838099807(10)4.3.2(11)20200610 4.3.3 (01)00884838099807(10)4.3.3(11)20210811 4.5.1 (01)00884838102910(10)4.5.1(11)20210321 4.5.2 (01)00884838102910(10)4.5.2(11)20210802 4.6.0 (01)00884838106963(10)4.6.0(11)20211014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0549-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0549-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-09	2022-02-01

Product code MSX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)