PlainRecalls
FDA Devices Moderate Class II Terminated

MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915

Reported: August 28, 2019 Initiated: July 9, 2019 #Z-2343-2019

Product Description

MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915

Reason for Recall

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

Details

Units Affected
44
Distribution
AL AR AZ CA CO CT DC DE FL GA GU 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
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 44.
Why was this product recalled?
Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 28, 2019. Severity: Moderate. Recall number: Z-2343-2019.