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Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is ...

FDA Device Recall #Z-0306-2021 — Class II — September 21, 2020

Recall Summary

Recall Number Z-0306-2021
Classification Class II — Moderate risk
Date Initiated September 21, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GE Healthcare, LLC
Location Waukesha, WI
Product Type Devices
Quantity 64 devices

Product Description

Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Reason for Recall

There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, NC, NE, NJ, PA, TX, VA, WA, and WI. The countries of Australia, Austria, Belgium, Canada, China, Denmark, Estonia, Finland, France, Japan, Kuwait, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

Lot / Code Information

Model 5995000-5; Lot/Serial Numbers as below: REVVX1800093CN REVVX1700044CN REVVX1900040CN REVVX2000001CN REV2A1900002CN REV2A2000014CN REVVX2000031CN REV2A2000013CN REVVX1600023CN REVVX1800015CN REVVX1900092CN REV2A2000006CN REVVX1900003CN REV2A2000003CN REV2A2000015CN REV2A1900003CN REVVX1800061CN REV2A2000007CN REVVX1700078CN REVVX1900071CN REVVX1900006CN REVVX1900003CN REVVX1800124CN REVVX1800030CN 441066CN8 00000436942CN7 REV2A2000010CN 00000442968CN4 REVVX1900049CN 00000439505CN9 REVVX1700064CN 00000440315CN0 REV2A2000017CN DUMFMI25490001 REV2A2000001CN 00000442412CN3 REV2A2000002CN REVVX1700054CN REVVX1800100CN REV2A2000012CN REVVX1800040CN REVVX1600046CN REV2A2000016CN REGGL2000003YC REVVX1900013CN REVVX1600030CN REV2A1900001CN REVVX1700117CN REVVX1800083CN REVVX1700106CN 00000440441CN4 REV2A2000018CN REV2A1900005CN REV2A2000009CN 00000438438CN4 REVVX1900102CN REV2A2000011CN REV2A2000004CN DUMFMI25490005 4 included units with lot/serials not available.

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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