FDA Device recall Z-2666-2025
MAGNETOM Verio Dot Upgrade
- FDA Device
- Class I
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class I recall of MAGNETOM Verio Dot Upgrade 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-2666-2025 |
| 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 Verio Dot Upgrade. Model Number: 10684334.
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: 10684334. UDI Numbers: (01)04056869006680(21)162012, (01)04056869006680(21)162055, (01)04056869006680(21)…Model Number: 10684334. UDI Numbers: (01)04056869006680(21)162012, (01)04056869006680(21)162055, (01)04056869006680(21)162039, (01)04056869006680(21)162002, (01)04056869006680(21)162014, (01)04056869006680(21)162069, (01)04056869006680(21)162083, (01)04056869006680(21)162075, (01)04056869006680(21)162028, (01)04056869006680(21)162060, (01)04056869006680(21)162035, (01)04056869006680(21)162038, (01)04056869006680(21)162016, (01)04056869006680(21)62040, (01)04056869006680(21)162036, (01)04056869006680(21)162079, (01)04056869006680(21)162054, (01)04056869006680(21)162088, (01)04056869006680(21)162071, (01)04056869006680(21)162078, (01)04056869006680(21)62032, (01)04056869006680(21)62037, (01)04056869006680(21)162077, (01)04056869006680(21)162042, (01)04056869006680(21)162025, (01)04056869006680(21)162082, (01)04056869006680(21)162085, (01)04056869006680(21)162026, (01)04056869006680(21)62027, (01)04056869006680(21)162040, (01)04056869006680(21)162032, (01)04056869006680(21)162072, (01)040 |
|---|
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-2666-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.