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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67959

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

Open FDA event record

Event summary

Timeline bucket
April 03, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Boston Scientific Corporation

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

iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.

Z-1487-2014
Recall number
Z-1487-2014
Initiated
April 03, 2014
Classification
Class II
Status
Terminated
Quantity
9 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec, the Longview distance measurement may

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec, the Longview distance measurement may display an inaccurate value that is double the actual distance.

Code information

Model Numbers: H749ILAB120CART0 H749ILAB120INS0 H749ILAB120N2710 Serial numbers: 4219, 4900, 5701, 5827 7516, 7517, 7607 8407, 8434. the different UPNs represent minor level differences in configuration relative to mobility and no difference in any essential components or software.

Distribution pattern

USA Nationwide Distribution in the states of NY, NC, DC, FL, PA