MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution high signal-to-noise ratio, with short scan times. The Signa¿ Excite MR system with Surgical Option is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra

Recall Insight

This FDA Devices action (record #Z-2527-2018) was formally reported on August 1, 2018, with the manufacturer initiating the action on March 30, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. GE Medical Systems, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records indicate 54 units total units are affected.

The documented reason for this recall is: There is a potential safety issue with the table transfer release of the MR Surgical Suite System which may cause an unexpected loss of function of the patient transfer mechanism that allows the patient to be moved from… Distribution data in the federal record shows the product reached: US Nationwide distribution to AZ, CA, CO, FL, IL, KS, MI, MN, NY, OH, PA, TX, UT, VA, WI. Worldwide distribution to Austria, Brazil, China, Czech Republic, France, Germany, India, Italy, Japan, Korea, Kuwait, South…. 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 8 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.