Recall Z-2004-2021— GE Healthcare, LLC
Class II · Completed
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2021-03-19. It names 3 FDA 510(k) clearances: K191777, K163213, K133705. Product: Revolution CT. Reason: GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Completed
- Initiated
- 2021-03-19
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
3 on FDA's record- K191777 — Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
- K163213 — Revolution CT
- K133705 — 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 CT
Reason for recall
GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
Data sourced from openFDA. This site is unofficial and independent of the FDA.