| Date Initiated by Firm | January 03, 2022 |
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| Create Date | February 01, 2022 |
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| Recall Status1 |
Terminated 3 on April 11, 2024 |
| Recall Number | Z-0549-2022 |
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| Recall Event ID |
89489 |
| Product Classification |
System, network and communication, physiological monitors - Product Code MSX
|
| 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 |
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| Code Information |
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 |
Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
|
| For Additional Information Contact | Philips Customer Services
800-722-9377 |
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Manufacturer Reason
for Recall | eCareManager (eCM) Sentry Score software not approved for use |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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 - eCMSentryScore@Philips.com
- 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: eicusupport@philips.com |
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| Quantity in Commerce | 36 units |
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| Distribution | Worldwide distribution - US Nationwide and the country of Australia. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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