Recall Z-0431-2026— Siemens Medical Solutions USA, Inc
Class I · Ongoing
Class I FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2025-10-01. It names one FDA 510(k) clearance: K231587. Product: MAGNETOM Cima.X Upgrade. Model Number: 11689304.. Reason: There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-10-01
- 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 Cima.X Upgrade. Model Number: 11689304.
Reason for recall
There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Data sourced from openFDA. This site is unofficial and independent of the FDA.