Z-2464-2012Class II

Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and...

Name: Z-2464-2012 Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and...
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-09-12
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-09-12 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager on 2012-09-12. FDA classified it as Class II and gives the reason as "When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with respect to the...". 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-2464-2012
Classification: Class II
Status: Terminated
Initiated: 2012-09-12
Posted: 2012-09-26
Terminated: 2014-01-14
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with respect to the head-foot direction, the coil can heat up in the area of the electronic housing (white plastic lids).
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Healthcare sent a Customer Safety Advisory Notice dated September 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter included updated instruction to all customers. For questions regarding this recall call 610-219-6300.
Quantity in commerce: 370
Distribution: Nationwide Distribution - USA including Washington, DC and AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI and Puerto Rico.
Product codes and lots: Model numbers: 10276755 (Verio), 10684333 (Verio Dot), 10684334 (Verio Dot upgrade), 10432915 (Skyra), 10655588 (Spectra), and 10433372 (Biograph mMR)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2464-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2464-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-26

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