Recall Z-0860-2022— GE Healthcare, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2022-02-18. It names 2 FDA 510(k) clearances: K121676, K052293. Product: 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System. Reason: There is potential for the images to be flipped left to right..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-02-18
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
2 on FDA's record- K121676 — 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT
- K052293 — GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM
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
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
Reason for recall
There is potential for the images to be flipped left to right.
Data sourced from openFDA. This site is unofficial and independent of the FDA.