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eCareManager version 4.2.1, eCareManager version 4.3.2… recallZ-0549-2022 · Philips North America Llc · initiated Jan 3, 2022

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

eCareManager (eCM) Sentry Score software not approved for use

FDA root cause category: Under Investigation by firm

What the company is doing

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]

Recall details

Recall number
Z-0549-2022
Status
Terminated
Initiated by the company
Jan 3, 2022
Recalling firm
Philips North America Llc
Quantity
36 units
Product code
MSX
Distribution
Worldwide distribution - US Nationwide and the country of Australia.

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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