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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73673

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 10, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Visicu

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.

Z-1557-2016
Recall number
Z-1557-2016
Initiated
March 10, 2016
Classification
Class II
Status
Terminated
Recalling firm
Philips Visicu
Quantity
9

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software error. Two issues occur as a result of the software error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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

Code information

453564506091 eCareCoordinator 1.3

Distribution pattern

US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS.