FDA Device recall Z-2660-2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K17359…
- FDA Device
- Class I
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class I recall of MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K17359… by Siemens Medical Solutions Usa, citing there is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the desi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2660-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-08-28 |
| Published | 2025-10-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
Reason
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, 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.
Identifiers
| code_info | Model Number: 10432915. UDI Numbers: (01)04056869006703(21)45046, (01)04056869006703(21)45115, (01)04056869006703(21)45…Model Number: 10432915. UDI Numbers: (01)04056869006703(21)45046, (01)04056869006703(21)45115, (01)04056869006703(21)45398, (01)04056869006703(21)145760, (01)04056869006703(21)145811, (01)04056869006703(21)45549, (01)04056869006703(21)45834, (01)04056869006703(21)146099, (01)04056869006703(21)146110, (01)04056869006703(21)45047, (01)04056869006703(21)146093, (01)04056869006703(21)46066, (01)04056869006703(21)45788, (01)04056869006703(21)146082, (01)04056869006703(21)45124, (01)04056869006703(21)45185, (01)04056869006703(21)45332, (01)04056869006703(21)45466, (01)04056869006703(21)145390, (01)04056869006703(21)45732, (01)04056869006703(21)45918, (01)04056869006703(21)45380, (01)04056869006703(21)46182, (01)04056869006703(21)45735, (01)04056869006703(21)45233, (01)04056869006680(21)162026, (01)04056869006703(21)145008, (01)04056869006703(21)145473, (01)04056869006703(21)145095, (01)04056869006703(21)145664, (01)04056869006703(21)45200, (01)04056869006703(21)146098, (01)04056869006703(21) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2660-2025%22
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