Recall Z-0518-2025— GE Medical Systems, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2024-10-28. It names 3 FDA 510(k) clearances: K202966, K163331, K160618. Product: SIGNA Architect, Nuclear Magnetic Resonance Imaging System. Reason: Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning..
- Recalling firm
- GE Medical Systems, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-28
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
3 on FDA's record- K202966 — SIGNA Architect
- 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
SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Reason for recall
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Data sourced from openFDA. This site is unofficial and independent of the FDA.