Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR recallZ-2464-2012 · Siemens Medical Solutions USA, Inc · initiated Sep 12, 2012
Class II Terminated All recalls posted in September 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2464-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 12, 2012
- Posted by the FDA
- Sep 26, 2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 370
- Product code
- LNH
- FDA submissions
- K072237, K101347, K103429, K121160
- 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 description
Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
Code information (models, lots, serial numbers)
Model numbers: 10276755 (Verio), 10684333 (Verio Dot), 10684334 (Verio Dot upgrade), 10432915 (Skyra), 10655588 (Spectra), and 10433372 (Biograph mMR)
Other devices under the same FDA submission
1 device cleared under K072237, K101347, K103429, K121160 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MAGNETOM Verio 10684334Siemens Healthcare GmbH · System, nuclear magnetic resonance imaging3 recalls1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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