Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 4, 2013
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, calcula
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 obstetr…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Healthcare, LLC recalled GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medic… - a moderate-severity action.
GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medic… was recalled by Ge Healthcare, LLC in September 4, 2013. Reason: GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility …. Check the official notice for the remedy. Verify recall #Z-2098-2013 with the FDA Devices before acting.
The recall
Ge Healthcare, LLC issued this moderate-severity FDA Devices recall-GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility ….
- Moderate
- severity level
- 225 units
- affected scope
- Class II
- classification
- September 4, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2098-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2098-2013) was formally reported on September 4, 2013, with the manufacturer initiating the action on August 7, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Ge Healthcare, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records list the affected scope as 225.
The documented reason for this recall is: 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 syste… Distribution data in the federal record shows the product reached: 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 KO…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
225
Related Recalls
6
3 from same agency
Product description
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.
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,
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2098-2013 |
| Date reported | September 4, 2013 |
| Date initiated | August 7, 2013 |
| Recalling firm | Ge Healthcare, LLC |
| Firm location | Waukesha, WI |
| Affected scope | 225 |
| Distribution | 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… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2098-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ge Healthcare, LLC. Units affected: 225.
Why was this product recalled? ▼
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,
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 4, 2013. Severity: Moderate. Recall number: Z-2098-2013.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2098-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 4, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.