Recall Z-2344-2019— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2019-07-09, terminated 2020-04-23. It names one FDA 510(k) clearance: K121160. Product: MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643. Reason: Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-09
- Terminated
- 2020-04-23
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643
Reason for recall
Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.