eCareCoordinator allows the customer to schedule patient tasks — Class II medical device recall Z-1557-2016
Terminated recall by Philips Visicu, reported 2016-05-04, distributed in FL, KS, MA, MI, MS, PA. The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adhe
| Recall number | Z-1557-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Visicu, Baltimore, MD, United States |
| Recall initiated | 2016-03-10 |
| Classified | 2016-04-22 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2017-10-27 |
| Distributed | FL, KS, MA, MI, MS, PA |
| Quantity | 9 |
| Reason classes | software |
Product
eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.