Z-2343-2019Class II

MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915

Name: Z-2343-2019 MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-07-09
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-07-09 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915 on 2019-07-09. FDA classified it as Class II and gives the reason as "Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2343-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-09
Posted: 2019-08-22
Terminated: 2020-04-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
Root cause tag: design
FDA root cause: Device Design
Action: 1. review the System Owner Manual chapter 1.3.3 Quench emergency plan and the section regarding defective vent line. 2. follow the standard emergency procedures you have in place in the event of system failures. 3.A Siemens Service Technician will conduct an inspection to verify that your system has a vertical outlet. If a vertical outlet is present, no further action is required. In the event your system is equipped with a horizontal outlet, the Siemens Service Technician will ensure that the port for the drop-off plate is adequately blanked off or sealed. 4.service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. 5. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. By signing this document you are acknowledging that you have read and understand the content therein. If you have any question, please contact Meredith Adams, Telephone 610-448-6461 and E-Mail: [email protected]
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2343-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2342-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2343-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2344-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2345-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22

Product code LNH

K111242Class IIMagnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. / cleared 2011-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)