FDA · Medical device recall

GE Healthcare Discovery RT… and 16 more products

Dec. 11, 2024 Class II

Date: Dec. 11, 2024
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Ongoing
Filed 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 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 pattern: Worldwide distribution.

17 products in this recall

GE Healthcare Discovery RT…

Product: GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
Quantity: 11 units
Codes and lots: UDI/DI 00840682118699, Serial/Sales Order Numbers: CBDYG2400058HM, CBDYG2400057HM, CBDYG2400056HM, CBDYG2400051HM, CBDYG2400052HM, CBDYG2400040HM, CBDYG2400053HM, CBDYG2400060HM, CBDYG2400054HM, CBDYG2400055HM, CBDYG2400059HM,
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0600-2025

GE Healthcare Optima 520…

Product: GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
Quantity: 11 units
Codes and lots: UDI/DI 00840682102568, Serial/Sales Order Numbers: CBDBG2400051HM, CBDBG2400048HM, CBDBG2400053HM, CBDBG2400049HM, CBDBG2400050HM, CBDBG2400052HM, CBDBG2400054HM, CBDBG2400055HM, CBDBG2400056HM, CBDBG2400057HM, CBDBG2400047HM
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0601-2025

GE Healthcare Optima 680 Expert…

Product: GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
Quantity: 8 units
Codes and lots: UDI/DI 00840682146937, Serial/Sales Order Numbers: CBDXG2400054HM, CBDXG2400059HM, CBDXG2400055HM, CBDXG2400058HM, CBDXG2400057HM, CBDXG2400060HM, CBDXG2400061HM, CBDXG2400056HM
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0602-2025

GE Healthcare Revolution ACE…

Product: GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
Quantity: 5 units
Codes and lots: UDI/DI 00840682146159, Serial/Sales Order Numbers: CBDAG2400021HM, CBDAG2400023HM, CBDAG2400024HM, CBDAG2400020HM, CBDAG2400022HM
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0603-2025

GE Healthcare Revolution Advance…

Product: GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
Quantity: 10 units
Codes and lots: UDI/DI 00195278385215, Serial/Sales Order Numbers: CBDLG2400031HM, CBDLG2400035HM, CBDLG2400034HM, CBDLG2400038HM, CBDLG2400036HM, CBDLG2400033HM, CBDLG2400037HM, CBDLG2400032HM, CBDLG2400039HM, CBDLG2400040HM
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0604-2025

GE Healthcare Revolution Ascend…

Product: GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
Quantity: 16 units
Codes and lots: UDI/DI 00840682146173, Serial/Sales Order Numbers: CBDWG2400109HM, CBDWG2400103HM, CBDWG2400102HM, CBDWG2400096HM, CBDWG2400111HM, CBDWG2400106HM, CBDWG2400115HM, CBDWG2400113HM, CBDWG2400105HM, CBDWG2400112HM, CBDWG2400116HM, CBDWG2400114HM, CBDWG2400107HM, CBDWG2400104HM, CBDWG2400110HM, CBDWG2400108HM
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0605-2025

GE Healthcare Revolution Ascend Elite…

Product: GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
Quantity: 4 units
Codes and lots: UDI/DI 00195278718129, Serial/Sales Order Numbers: CBFLG2400002HM, CBFLG2400005HM, CBFLG2400004HM, CBFLG2400003HM
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0606-2025

GE Healthcare Revolution Eagle…

Product: GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
Quantity: 4 units
Codes and lots: UDI/DI 00195278385215, Serial/Sales Order Numbers: CBDPG2400006HM, CBDPG2400005HM, CBDPG2400004HM, CBDPG2400007HM
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0607-2025

GE Healthcare Revolution EVO…

Product: GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
Quantity: 2 units
Codes and lots: UDI/DI 00840682109796, Serial/Sales Order Numbers: CBDGG2400018HM, CBDGG2400017HM
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0608-2025

GE Healthcare Revolution Frontier…

Product: GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system
Quantity: 3 units
Codes and lots: UDI/DI 00195278362230: 1) 5232085-213, Serial/Sales Order Numbers: CBDUG2400017HM, CBDUG2400016HM; 2) 5873009, Serial/Sales Order Numbers: CBDUG2400014HM
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0609-2025

GE Healthcare Revolution Maxima…

Product: GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system
Quantity: 72 units
Codes and lots: 1) 6665000-2, UDI/DI 00840682146180, Serial/Sales Order Numbers: CBDMG2400130HM, CBDMG2400134HM; 2) 6670000-2, UDI/DI 00840682146180, Serial/Sales Order Numbers: CBDMG2400114HM, CBDMG2400127HM, CBDMG2400128HM, CBDMG2400129HM, CBDMG2400131HM, CBDMG2400132HM, CBDMG2400133HM, CBDMG2400135HM, CBDMG2400136HM, CBDMG2400137HM, CBDMG2400138HM, CBDMG2400139HM, CBDMG2400140HM, CBDMG2400141HM, CBDMG2400142HM, CBDMG2400143HM, CBDMG2400144HM, CBDMG2400145HM, CBDMG2400146HM, CBDMG2400147HM, CBDNG2400007HM, CBDNG2400010HM; UDI/DI 00195278686718, Serial/Sales Order Numbers: CBDOG2400032HM, CBDOG2400033HM, CBDOG2400034HM, CBDOG2400035HM; 3) 6670000-200, UDI/DI 00195278686718, Serial/Sales Order Numbers: CBFMG2400171HM, CBFMG2400188HM, CBFMG2400149HM, CBFMG2400160HM, CBFMG2400148HM, CBFMG2400173HM, CBFMG2400166HM, CBFMG2400185HM, CBFMG2400152HM, CBFMG2400156HM, CBFMG2400157HM, CBFMG2400158HM, CBFMG2400159HM, CBFMG2400163HM, CBFMG2400177HM, CBFMG2400178HM, CBFMG2400179HM, CBFMG2400180HM, CBFMG2400153HM, CBFMG2400154HM, CBFMG2400150HM, CBFMG2400182HM, CBFMG2400184HM, CBFMG2400161HM, CBFMG2400165HM, CBFMG2400172HM, CBFMG2400155HM, CBFMG2400162HM, CBFMG2400174HM, CBFMG2400176HM, CBFMG2400168HM, CBFMG2400151HM, CBFMG2400169HM, CBFMG2400170HM, CBFMG2400175HM, CBFMG2400181HM, CBFMG2400183HM, CBFMG2400186HM, CBFMG2400187HM, CBFMG2400164HM, CBFMG2400167HM; 4) 6670000-6, UDI/DI 00840682146180, Serial/Sales Order Numbers: MA10G2400033YC, MA10G2400032YC, MA10G2400034YC
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0610-2025

GE Healthcare Revolution Maxima M…

Product: GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
Quantity: 3 units
Codes and lots: UDI/DI 0019527856860, Serial/Sales Order Numbers: CBDOG2400029HM, CBDOG2400031HM, CBDOG2400030HM
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0611-2025

GE Healthcare Revolution Maxima Select…

Product: GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
Quantity: 10 units
Codes and lots: UDI/DI 00195278520852, Serial/Sales Order Numbers: CBFSG2400030HM, CBFSG2400032HM, CBFSG2400037HM, CBFSG2400034HM, CBFSG2400031HM, CBFSG2400035HM, CBFSG2400029HM, CBFSG2400028HM, CBFSG2400033HM, CBFSG2400036HM
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0612-2025

GE Healthcare Operator Console Upgrade Types…

Product: GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; X-ray/computed tomography system
Quantity: 5 units
Codes and lots: UDI/DI 00195278466488, Serial/Sales Order Numbers: 5469298, 5471981, 5461542, 5469371 4616154
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0613-2025

GE Healthcare Operator Console Upgrade Types…

Product: GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Elite Select), Non-EU: BrightSpeed Elite, BrightSpeed Elite Select; X-ray/computed tomography system
Quantity: 4 units
Codes and lots: UDI/DI 00195278505798, Serial/Sales Order Numbers: 203364, 8102303, 5468897, 5469818
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0614-2025

GE Healthcare Operator Console Upgrade Types…

Product: GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
Quantity: 3 units
Codes and lots: UDI/DI 00840682102490, Serial/Sales Order Numbers: 5476353, 5472107, 5472476
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0615-2025

GE Healthcare Operator Console Upgrade Types…

Product: GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD
Quantity: 1 unit
Codes and lots: UDI/DI N/A, Serial/Sales Order Numbers: 5472442
Recall started: Nov. 5, 2024
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Component design/selection
What the company told customers: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0616-2025

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0600-2025, Z-0601-2025, Z-0602-2025, Z-0603-2025, Z-0604-2025, Z-0605-2025, Z-0606-2025, Z-0607-2025 and others. The agency record governs; check it and the company before acting.

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