Recall Z-0141-2022— GE Healthcare, LLC
Class II · Completed
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2021-08-26. It names 2 FDA 510(k) clearances: K121676, K052293. Product: 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system. Reason: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Completed
- Initiated
- 2021-08-26
- 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 SIGNA HDxt MR System nuclear magnetic resonance imaging system
Reason for recall
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Data sourced from openFDA. This site is unofficial and independent of the FDA.