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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

GE Discovery, Optima, and Revolution CT Systems Recalled for Image Rotation

Agency Publication Date: December 4, 2024
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Summary

GE HealthCare has recalled 172 units of Discovery, Optima, and Revolution series CT systems and specific operator console upgrades because images may appear rotated. This defect occurs primarily in helical, cine, and cardiac scan modes, where each subsequent image rotates by an increasing amount, reaching up to 56 degrees. While the anatomy rotates as a whole without distortion, small degrees of rotation may be difficult to detect, potentially leading to incorrect diagnosis. No injuries or incidents have been reported, but the defect may require patients to undergo rescans, resulting in unnecessary radiation exposure.

Risk

The defect causes CT images to rotate progressively by as much as 56 degrees depending on the gantry speed and scan duration. This rotation can lead to the misinterpretation of anatomical positioning or necessitate repeat imaging, which exposes patients to additional radiation.

What You Should Do

  1. This recall affects GE Healthcare Discovery, Optima, and Revolution series CT systems and operator console upgrade types (B79632DA, B80212DA, B80522DA, and B80662DA) manufactured in China.
  2. Identify if your system is affected by checking the model number and serial number on the device label or the operator console. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled systems for clinical diagnostic procedures if you notice image rotation.
  4. Contact GE Healthcare or your authorized distributor immediately to arrange for a system correction or software update.
  5. Report any adverse events or quality problems to the FDA's MedWatch program at 1-800-332-1088.
  6. For additional questions regarding this recall, call the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: GE Healthcare Discovery RT
Model / REF:
2374681-17
Serial Numbers:
CBDYG2400058HM
CBDYG2400057HM
CBDYG2400056HM
CBDYG2400051HM
CBDYG2400052HM
CBDYG2400040HM
CBDYG2400053HM
CBDYG2400060HM
CBDYG2400054HM
CBDYG2400055HM
CBDYG2400059HM
UDI:
00840682118699
Product: GE Healthcare Optima 520
Model / REF:
5439126
Serial Numbers:
CBDBG2400051HM
CBDBG2400048HM
CBDBG2400053HM
CBDBG2400049HM
CBDBG2400050HM
CBDBG2400052HM
CBDBG2400054HM
CBDBG2400055HM
CBDBG2400056HM
CBDBG2400057HM
CBDBG2400047HM
UDI:
00840682102568
Product: GE Healthcare Optima 680 Expert
Model / REF:
6670000
Serial Numbers:
CBDXG2400054HM
CBDXG2400059HM
CBDXG2400055HM
CBDXG2400058HM
CBDXG2400057HM
CBDXG2400060HM
CBDXG2400061HM
CBDXG2400056HM
UDI:
00840682146937
Product: GE Healthcare Revolution ACE
Model / REF:
6670000-3
Serial Numbers:
CBDAG2400021HM
CBDAG2400023HM
CBDAG2400024HM
CBDAG2400020HM
CBDAG2400022HM
UDI:
00840682146159
Product: GE Healthcare Revolution Advance
Model / REF:
5849504
Serial Numbers:
CBDLG2400031HM
CBDLG2400035HM
CBDLG2400034HM
CBDLG2400038HM
CBDLG2400036HM
CBDLG2400033HM
CBDLG2400037HM
CBDLG2400032HM
CBDLG2400039HM
CBDLG2400040HM
UDI:
00195278385215
Product: GE Healthcare Revolution Ascend
Model / REF:
6969000-100
Serial Numbers:
CBDWG2400109HM
CBDWG2400103HM
CBDWG2400102HM
CBDWG2400096HM
CBDWG2400111HM
CBDWG2400106HM
CBDWG2400115HM
CBDWG2400113HM
CBDWG2400105HM
CBDWG2400112HM
CBDWG2400116HM
CBDWG2400114HM
CBDWG2400107HM
CBDWG2400104HM
CBDWG2400110HM
CBDWG2400108HM
UDI:
00840682146173
Product: GE Healthcare Revolution Ascend Elite
Model / REF:
6967000-100
Serial Numbers:
CBFLG2400002HM
CBFLG2400005HM
CBFLG2400004HM
CBFLG2400003HM
UDI:
00195278718129
Product: GE Healthcare Revolution Eagle
Model / REF:
5849504-3
Serial Numbers:
CBDPG2400006HM
CBDPG2400005HM
CBDPG2400004HM
CBDPG2400007HM
UDI:
00195278385215
Product: GE Healthcare Revolution EVO
Model / REF:
5454001-260
Serial Numbers:
CBDGG2400018HM
CBDGG2400017HM
UDI:
00840682109796
Product: GE Healthcare Revolution Frontier
Model / REF:
5232085-213
5873009
Serial Numbers:
CBDUG2400017HM
CBDUG2400016HM
CBDUG2400014HM
UDI:
00195278362230
Product: GE Healthcare Revolution Maxima
Model / REF:
6665000-2
6670000-2
6670000-200
6670000-6
Serial Numbers (72):
CBDMG2400130HM
CBDMG2400134HM
CBDMG2400114HM
CBDMG2400127HM
CBDMG2400128HM
CBDMG2400129HM
CBDMG2400131HM
CBDMG2400132HM
CBDMG2400133HM
CBDMG2400135HM
CBDMG2400136HM
CBDMG2400137HM
CBDMG2400138HM
CBDMG2400139HM
CBDMG2400140HM
CBDMG2400141HM
CBDMG2400142HM
CBDMG2400143HM
CBDMG2400144HM
CBDMG2400145HM
CBDMG2400146HM
CBDMG2400147HM
CBDNG2400007HM
CBDNG2400010HM
CBDOG2400032HM
CBDOG2400033HM
CBDOG2400034HM
CBDOG2400035HM
CBFMG2400171HM
CBFMG2400188HM
CBFMG2400149HM
CBFMG2400160HM
CBFMG2400148HM
CBFMG2400173HM
CBFMG2400166HM
CBFMG2400185HM
CBFMG2400152HM
CBFMG2400156HM
CBFMG2400157HM
CBFMG2400158HM
CBFMG2400159HM
CBFMG2400163HM
CBFMG2400177HM
CBFMG2400178HM
CBFMG2400179HM
CBFMG2400180HM
CBFMG2400153HM
CBFMG2400154HM
CBFMG2400150HM
CBFMG2400182HM
UDI:
00840682146180
00195278686718
Product: GE Healthcare Revolution Maxima M
Model / REF:
6670000-2
Serial Numbers:
CBDOG2400029HM
CBDOG2400031HM
CBDOG2400030HM
UDI:
0019527856860
Product: GE Healthcare Revolution Maxima Select
Model / REF:
6670000-55
Serial Numbers:
CBFSG2400030HM
CBFSG2400032HM
CBFSG2400037HM
CBFSG2400034HM
CBFSG2400031HM
CBFSG2400035HM
CBFSG2400029HM
CBFSG2400028HM
CBFSG2400033HM
CBFSG2400036HM
UDI:
00195278520852
Product: GE Healthcare Operator Console Upgrade B79632DA
Model / REF:
B79632DA
Serial Numbers:
5469298
5471981
5461542
5469371
4616154
UDI:
00195278466488
Product: GE Healthcare Operator Console Upgrade B80212DA
Model / REF:
B80212DA
Serial Numbers:
203364
8102303
5468897
5469818
UDI:
00195278505798
Product: GE Healthcare Operator Console Upgrade B80522DA
Model / REF:
B80522DA
Serial Numbers:
5476353
5472107
5472476
UDI:
00840682102490
Product: GE Healthcare Operator Console Upgrade B80662DA
Model / REF:
B80662DA
Serial Numbers:
5472442

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95704
Status: Active
Manufacturer: GE Healthcare (China) Co., Ltd.
Sold By: GE Healthcare Authorized Dealers
Manufactured In: China
Units Affected: 17 products (11 units; 11 units; 8 units; 5 units; 10 units; 16 units; 4 units; 4 units; 2 units; 3 units; 72 units; 3 units; 10 units; 5 units; 4 units; 3 units; 1 unit)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.