Recall Z-1928-2016— GE Healthcare, LLC

Name: FDA recall Z-1928-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-09

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2016-05-09, terminated 2018-07-11. It names one FDA 510(k) clearance: K123068. Product: Optima 1.5T MR430s MR Scanner, a diagnostic imaging device. Reason: The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-05-09
Terminated: 2018-07-11
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K123068 — OPTIMA MR 430SGe Medical Systems, LLC·cleared 2012-11-13

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

Optima 1.5T MR430s MR Scanner, a diagnostic imaging device

Reason for recall

The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.

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