FDA has classified 5 GE HealthCare Allia angiographic X-ray system recalls as Class 2 events tied to a potential electrical-shock risk for service personnel.
Affected systems include Allia IGS 3 Pulse, Allia IGS 5 Pulse, Allia IGS 7 Pulse, Allia IGS Pulse, and Allia Moveo angiographic X-ray systems. FDA posted the recall entries on June 5.
The recalls involve certain IGS systems equipped with Gaia generators. FDA records state that an electrical cable issue could create shock risk when service personnel perform installation, maintenance, or troubleshooting inside the C-FRT cabinet while power is on.
“GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators,” FDA recall records state.
GE Medical Systems initiated the correction on April 20. FDA records list the cause as device design.
Use of the systems can continue, according to FDA recall records. Customers were instructed that qualified service personnel should follow the applicable service manual and use personal protective equipment for electrical hazards when working inside the cabinet while power is on.
If loose or visibly exposed wires are seen on the Iris Power Cable during servicing, FDA records state that personnel should follow the electrical lockout/tagout procedure described in the service manual.
The affected units were distributed worldwide, including nationwide U.S. distribution. FDA records list the recall status as open and classified.
A French safety notice from ANSM also lists the same field safety action for Allia IGS 3, 5, 7, Pulse, and Moveo systems from GE Medical Systems SCS.
Companies:GE HealthCare, U.S. Food and Drug Administration
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