CLASS II Device recall · Reported 4 May 2016 · FDA Enforcement Report
eCareCoordinator allows the customer to schedule patient recalled
Philips Visicu is recalling eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight, distributed in Florida, Kansas, Massachusetts, Michigan, Mississippi, Pennsylvania. The recall was initiated on 10 Mar 2016 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-1557-2016
- FDA event ID
- 73673
- Recalling firm
- Philips Visicu, Baltimore, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Mar 2016
- FDA classified
- 22 Apr 2016
- Reported
- 4 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 10 Mar 2016 | Recall initiated by company | |
| 22 Apr 2016 | Classified by FDA | +43 days |
| 4 May 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the date 14 days later. An error message is generated and forwarded to operations. Subsequently, for days in which no task was generated, patient will not get a reminder on the tablet to take a measurement. If the pa
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.
Where it was distributed
US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS.
Questions about this recall
Is eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight recalled?
Yes. Philips Visicu recalled eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight on 10 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1557-2016.
Why was it recalled?
The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the date 14 days later. An error message is generated and forwarded to operations. Subsequently, for days in which no task was generated, patient will not get a reminder on the tablet to take a measurement. If the pa
Which lots are affected?
453564506091 eCareCoordinator 1.3
Where was it sold?
US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS.
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 Visicu
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | eCare Coordinator recalled by Philips Visicu | Philips Visicu | Device Malfunction | Nationwide |
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