Recall Z-0549-2022 ยท MSX System, Network And Communication, Physiological Monitors
Philips North America Llc
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
| Date | Jan 3, 2022 |
| Status | Terminated |
| Reason | eCareManager (eCM) Sentry Score software not approved for use |
| 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 - eCMSentryScore@Philips.com - FedEx Please use the return |
| Quantity | 36 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.