Recall Z-0600-2022— GE Healthcare, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2021-12-23. It names 3 FDA 510(k) clearances: K202238, K163331, K160618. Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.. 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
3 on FDA's record- K202238 — SIGNA Artist
- K163331 — Discovery MR750 3.0T +4 more
- K160618 — Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
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 Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.
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.