GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
Summary
The FDA issued a Class II for GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomogr by GE Healthcare (China) Co., Ltd.. Reason: GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades .
Details
Source
Device Recall
External ID
Z-0605-2025
Action Date
2024-12-11
Status
Ongoing
Category
device
Product Description
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
Lot/Code Info: UDI/DI 00840682146173, Serial/Sales Order Numbers: CBDWG2400109HM, CBDWG2400103HM, CBDWG2400102HM, CBDWG2400096HM, CBDWG2400111HM, CBDWG2400106HM, CBDWG2400115HM, CBDWG2400113HM, CBDWG2400105HM, CBDWG2400112HM, CBDWG2400116HM, CBDWG2400114HM, CBDWG2400107HM, CBDWG2400104HM, CBDWG2400110HM, CBDWG2400108HM
Quantity Affected: 16 units
Reason for Recall
GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-05
Company
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 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Healthcare (China) Co., Ltd. has 24 FDA actions in our database, including 24 recalls.
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 Healthcare (China) Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Healthcare (China) Co., Ltd. have FDA actions?
GE Healthcare (China) Co., Ltd. has 24 FDA actions in our database, including 24 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0605-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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