CLASS II Device recall · Reported 9 Feb 2022 · FDA Enforcement Report
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager recalled
Philips North America is recalling eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager, distributed nationwide in the US. The recall was initiated on 3 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0549-2022
- FDA event ID
- 89489
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jan 2022
- FDA classified
- 1 Feb 2022
- Reported
- 9 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Hidden Drug Ingredients
- Device type
- Medical Software
Timeline
| 3 Jan 2022 | Recall initiated by company | |
| 1 Feb 2022 | Classified by FDA | +29 days |
| 9 Feb 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
eCareManager (eCM) Sentry Score software not approved for use
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the country of Australia.
Questions about this recall
Is eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager recalled?
Yes. Philips North America recalled eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager on 3 Jan 2022. The recall is Class II and its status is Terminated. Recall number Z-0549-2022.
Why was it recalled?
eCareManager (eCM) Sentry Score software not approved for use
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US Nationwide and the country of Australia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips North America
All 531Other Medical Software recalls
All 903| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Brilliance recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips IQon Spectral CT Product Codes recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Ingenuity CT Product Codes recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled | Philips North America | Device Malfunction | MA |
| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |