🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: September 21, 2020 GE Healthcare Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GE Healthcare, LLC
Reason for Recall:
There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0306-2021

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