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

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 indicate 225 units are affected.

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.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.