Z-0467-2016Class II

MAGNETOM systems, magnetic resonance diagnostic devices (MRDD)

Name: Z-0467-2016 MAGNETOM systems, magnetic resonance diagnostic devices (MRDD)
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-12-07
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-12-07 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of MAGNETOM systems, magnetic resonance diagnostic devices (MRDD) on 2015-12-07. FDA classified it as Class II and gives the reason as "Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Any restriction, obstruction, or improper installation of the quench line may cause the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0467-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-07
Posted: 2015-12-22
Terminated: 2017-06-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Any restriction, obstruction, or improper installation of the quench line may cause the helium gas to be blown directly into the magnet room or other areas. This could lead to displacement of oxygen, cause cold burns, and/or pose a risk to users, patient or others.
FDA root cause: Other
Action: Siemens sent an Customer Advisory letter dated December 7, 2015, certified mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter notifies customers of the potential injuries, which may result of improperly installed quench lines. The letter indicates it is the system's owner who is responsible for installing the quench line per the requirements. If Siemens installed the quench lines, the consignee is directed to contact Siemens, who will inspect the quench lines during next maintenance visit. Siemens will monitor service reports for affected sites. For further questions please call ( 610) 219-6300.
Quantity in commerce: in US 3752 units
Distribution: Nationwide including : DC, PR, Virgin Islands and Bermuda
Product codes and lots: all units distributed since 1991

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0467-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0467-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-22

Product code LNH

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)