FDA Class II Recall: GE Healthcare Operator Console Upgrade Types, FRU Spare… by GE Healthcare (China) Co., Ltd. — Recall Details

Key facts

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from GE Healthcare (China) Co., Ltd.. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from GE Healthcare (China) Co., Ltd. should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to GE Healthcare (China) Co., Ltd. directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

GE Healthcare (China) Co., Ltd.’s FDA history

Argus HQ has recorded 24 total FDA actions tied to GE Healthcare (China) Co., Ltd.: 0 warning letters, 24 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the recall class for GE Healthcare (China) Co., Ltd.'s recall?

FDA classified this recall as Class II. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Why was GE Healthcare Operator Console Upgrade Types, FRU Spare Part recalled?

FDA's recall record states the reason as: 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.

Who should I contact about this recall?

Contact GE Healthcare (China) Co., Ltd. directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has GE Healthcare (China) Co., Ltd. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 24 total FDA actions tied to GE Healthcare (China) Co., Ltd., including 24 recalls and 0 warning letters.

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