MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Pending LLM rewrite. Source: FDA_DEVICE Z-2666-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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