Recall Z-2464-2012— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2012-09-12, terminated 2014-01-14. It names 4 FDA 510(k) clearances: K121160, K103429, K101347 and 1 more. Product: Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager. Reason: 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)..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-12
- Terminated
- 2014-01-14
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
4 on FDA's record- K121160 — MAGNETOM SPECTRA
- K103429 — BIOGRAPH MMR
- K101347 — MAGNETOM AERA; MAGNETOM SKYRA
- K072237 — MAGNETOM VERIO
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.