FDAFDA · Food and drugs·Recall number Z-1779-2024
GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
Published May 15, 2024 · Recall initiated: March 18, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Medical Systems, SCS
- Distributor
- 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, Taiwan, Turkey, Vietnam
- Lot
- UDI/DI 00840682141581, Serial Numbers: M4-23-049
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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