Recall Z-0603-2022— GE Healthcare, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2021-12-23. It names 2 FDA 510(k) clearances: K121676, K052293. Product: GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIGNA HDxt, 1.5T SIGNA HDxt Mobile, 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant systems, nuclear magnetic resonance imaging systems.. Reason: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-12-23
- 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
GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIGNA HDxt, 1.5T SIGNA HDxt Mobile, 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant systems, nuclear magnetic resonance imaging systems.
Reason for recall
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Data sourced from openFDA. This site is unofficial and independent of the FDA.