GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.

Recall Insight

This FDA Devices action (record #Z-0256-2016) was formally reported on November 18, 2015, with the manufacturer initiating the action on August 31, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. GE Healthcare is listed as the recalling firm, operating out of Waukesha, WI. Federal records indicate 55 units are affected.

The documented reason for this recall is: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR … Distribution data in the federal record shows the product reached: Worldwide Distribution - US: Nationwide including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL, BULGARIA, CANADA, …. 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 11 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.