Recall Z-1430-2022— GE Healthcare, LLC

Name: FDA recall Z-1430-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-24

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2022-06-24. It names 3 FDA 510(k) clearances: K193282, K183231, K171128. Product: SIGNA Premier magnetic resonance scanner, model 5748519.. Reason: Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-06-24
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

3 on FDA's record

K193282 — SIGNA PremierGe Healthcare (Ge Medical Systems, LLC)·cleared 2020-04-10
K183231 — SIGNA PremierGe Medical Systems, LLC·cleared 2019-01-18
K171128 — SIGNA PremierGe Medical Systems, LLC·cleared 2017-07-14

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 Premier magnetic resonance scanner, model 5748519.

Reason for recall

Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.

Data sourced from openFDA. This site is unofficial and independent of the FDA.