Summary
The FDA issued a Class II for GE Healthcare Innova IGS 5, computed tomography x-ray system by GE Medical Systems, SCS. Reason: 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,.
Details
Source
Device Recall
External ID
Z-1777-2024
Action Date
2024-05-15
Status
Ongoing
Category
device
Product Description
GE Healthcare Innova IGS 5, computed tomography x-ray system
Lot/Code Info: UDI/DI 00840682124621, Serial Numbers: M2-23-042, M2-23-046, M2-23-048, M2-23-051, M2-24-001, M3-23-097, M3-23-098, M3-23-106, M3-23-108, M3-23-109, M3-23-111, M3-23-112, M3-23-114, M3-23-116, M3-23-123, M4-23-046, M4-23-053, M4-23-054, M4-23-055, M4-23-056, M4-24-001
Quantity Affected: 21 units
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.
Distribution
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-18
Company
Buc, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 151 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Medical Systems, SCS has 25 FDA actions in our database, including 9 recalls and 16 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems, SCS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems, SCS have FDA actions?
GE Medical Systems, SCS has 25 FDA actions in our database, including 9 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1777-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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