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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65880

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

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Event summary

Timeline bucket
August 07, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Healthcare, LLC

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

GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound. ViewPoint provides the user the ability to including images, drawings, and charts into medical reports. ViewPoint is designed to accept, transfer, display, calculate, store and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint displays to the user, can be used for diagnostic purposes. ViewPoint is intended for professional use only. ViewPoint is not intended to be used as an automated diagnosis system.

Z-2098-2013
Recall number
Z-2098-2013
Initiated
August 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
225

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements associated with obstetric reporting of the GE ViewPoint 6 system. The ViewPoint calculated Doppler PIV for veins could be incorrect. An incorrect calculation of the ductus venosus PIV could lead to false high risk for trisomy 13, 18, and 21,

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

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Inspect official wording and provenance

Reason for recall

GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements associated with obstetric reporting of the GE ViewPoint 6 system. The ViewPoint calculated Doppler PIV for veins could be incorrect. An incorrect calculation of the ductus venosus PIV could lead to false high risk for trisomy 13, 18, and 21,

Code information

software versions 6.2, 6.2.1, 6.3, and 6.3.1

Distribution pattern

Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of: ANDORRA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BRAZIL, BULGARIA, CANADA, CHILE, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, KUWAIT, MALAYSIA, Norway, OMAN, PALESTINIAN TERRITORY, OCCUPIED, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, and UNITED KINGDOM.