Recall Z-0815-2022— GE Healthcare, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2021-06-30. It names 2 FDA 510(k) clearances: K191777, K163213. Product: Revolution Apex, Revolution CT with Apex Edition. Reason: The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-06-30
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
2 on FDA's record- K191777 — Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
- K163213 — Revolution CT
K-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
Reason for recall
The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
Data sourced from openFDA. This site is unofficial and independent of the FDA.