GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems

Recall Insight

This FDA Devices action (record #Z-1783-2024) was formally reported on May 15, 2024, with the manufacturer initiating the action on March 18, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. GE Medical Systems, SCS is listed as the recalling firm, operating out of Buc, N/A. Federal records indicate 1 unit units are affected.

The documented reason for this recall is: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could res… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain,…. 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 2 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.