Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.

Recall Insight

This FDA Devices action (record #Z-1779-2017) was formally reported on April 19, 2017, with the manufacturer initiating the action on March 10, 2017. 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 971(412 US; 559 OUS) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certai… Distribution data in the federal record shows the product reached: United Kingdom, United Arab Emirates, Turkey, Thailand, Switzerland, Sweden, Spain, South Africa, Slovenia, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Norway, New Zealand, New Caledonia, Netherlands…. 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 9 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.