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

FDA device recall Z-2464-2012 · posted 2012-09-26 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

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).

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

LNH

Quantity affected

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, R

Date initiated

2012-09-12

Date posted

2012-09-26

Date terminated

2014-01-14

Location

Malvern, PA

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