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U.S. Department of Health and Human Services

Class 2 Device Recall Allia IGS 5

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 Class 2 Device Recall Allia IGS 5see related information
Date Initiated by FirmMarch 18, 2024
Date PostedMay 06, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1782-2024
Recall Event ID 94305
510(K)NumberK181403 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductGE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
Code Information UDI/DI 00195278719263, Serial Numbers: M3-23-117
Recalling Firm/
Manufacturer		 GE Medical Systems, SCS
283 rue de la Miniere
Buc France
For Additional Information ContactGE HealthCare Service
800-437-1171
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process control
ActionGE Healthcare issued an UGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/18/2024 via letter. The notice explained the issue, hazard, and requested the following actions be taken: Every day prior to first use of the device, perform a functional check of the gantry movements and images of your device to look for the following behaviors: 1. Abnormal noise during gantry movement. 2. Image misalignment. If any of the above is observed, DO NOT use the device and call GE HealthCare Service Immediately. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Post this letter in a visible location beside the product. GE HealthCare will schedule a service appointment to correct this potential issue in a timely manner. For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce1 unit
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWB
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