RecallRadar

FDA Device recall Z-2343-2019

MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915

On 2019-08-28 the FDA classified a Class II recall of MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915 by Siemens Medical Solutions Usa, citing potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2343-2019
ClassificationClass II
Statusterminated
Initiated2019-07-09
Published2019-08-28
Last updated2026-09-13 11:55 UTC
CompanySiemens Medical Solutions Usa
DistributionAL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, WY

Product

MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915

Reason

Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.

Identifiers

code_info
Serial # 46066 45732 46182 45735 45805 46171 45693 45886 45988 45881 46144 46044 46176 46179 46032 4623…Serial # 46066 45732 46182 45735 45805 46171 45693 45886 45988 45881 46144 46044 46176 46179 46032 46238 145161 46127 45774 45968 46196 46175 45681 46007 46021 46105 46142 45928 45815 46150 145302 45878 46239 46026 145403 45667 145536 45970 45839 45982 46145 46298 45777 46294

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2343-2019%22

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