'Risk of electrical shock' prompts recall of imaging systems
A handful of fluoroscopy units manufactured by GE HealthCare are the subject of a new recall by the U.S. Food and Drug Administration.
The Allia Angiographic series of systems made their way onto the FDA’s list due to an issue pertaining to the devices’ design. Affected systems include the Allia Moveo, Allia IGS 7 Pulse, Allia IGS 5 Pulse, Allia IGS 3 Pulse and the Allia IGS Pulse.
The FDA’s notice indicates that the Class 2 recall is due to an issue with the electrical cables on these systems.
“GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators," the notice reads. "This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.”
GE became aware of the issue in April. Shortly thereafter, the company issued Urgent correction letters to affected customers. Letters indicated that the systems can still be used routinely but encourage caution when performing any activity inside the cabinet while power is on. The letter reminds users who must service or conduct troubleshooting activities inside the C-FRT cabinet to wear appropriate personal protective equipment for electrical hazards. GE requested that affected users post a notice with a warning about the hazard in a visible location near the C-FRT cabinet.
If wires are exposed or loose, users should follow the electrical lockout/tagout procedure as described in the device's service manual. It is also recommended that customers reach out to their local GE representative with additional questions.
The affected units are in operation globally. No adverse events related to the recall have been reported thus far.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.