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.
Reported: November 4, 2020 Initiated: September 21, 2020 #Z-0306-2021
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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 64 devices
- Distribution
- 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.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by GE Healthcare, LLC. Units affected: 64 devices.
Why was this product recalled? ▼
There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 4, 2020. Severity: Moderate. Recall number: Z-0306-2021.
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