Recall Z-0306-2021— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2020-09-21, terminated 2022-12-28. It names one FDA 510(k) clearance: K191777. Product: 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: There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-09-21
- Terminated
- 2022-12-28
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.