CLASS I ONGOING Device recall · Reported 8 Oct 2025 · FDA Enforcement Report
Magnetom Verio Dot recalled by Siemens Medical Solutions USA
Siemens Medical Solutions USA is recalling Magnetom Verio Dot, distributed nationwide in the US. The recall was initiated on 28 Aug 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2665-2025
- FDA event ID
- 97530
- Recalling firm
- Siemens Medical Solutions USA, Malvern, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 28 Aug 2025
- FDA classified
- 30 Sep 2025
- Reported
- 8 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 28 Aug 2025 | Recall initiated by company | |
| 30 Sep 2025 | Classified by FDA | +33 days |
| 8 Oct 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
MAGNETOM Verio Dot. Model Number: 10684333.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.
Questions about this recall
Is Magnetom Verio Dot recalled?
Yes. Siemens Medical Solutions USA recalled Magnetom Verio Dot on 28 Aug 2025. The recall is Class I and its status is Ongoing. Recall number Z-2665-2025.
Why was it recalled?
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.
Which lots are affected?
Model Number: 10684333. UDI Numbers: (01)04056869006673(21)60060, (01)04056869006673(21)160040, (01)04056869006673(21)160028, (01)04056869006673(21)160021, (01)04056869006673(21)60108, (01)04056869006673(21)60121, (01)04056869006673(21)160019, (01)04056869006673(21)60091, (01)04056869006673(21)160020, (01)04056869006673(21)160043, (01)04056869006673(21)60062, (01)04056869006673(21)60061, (01)04056869006673(21)160029, (01)04056869006673(21)160038, (01)04056869006673(21)60086, (01)04056869006673(21)60126, (01)04056869006673(21)60047, (01)04056869006673(21)160036, (01)04056869006673(21)160003, (01)04056869006673(21)160042, (01)04056869006673(21)160024, (01)04056869006673(21)60092, (01)04056869006673(21)160035, (01)04056869006673(21)60102, (01)04056869006673(21)160039, (01)04056869006673(21)60112, (01)04056869006673(21)160030, (01)04056869006673(21)60099, (01)04056869006673(21)160007, (01)04056869006673(21)160001, (01)04056869006673(21)160006, (01)04056869006673(21)160009, (01)04056869006673(21)160033, (01)04056869006673(21)60053, (01)04056869006673(21)60070, (01)04056869006673(21)60101, (01)04056869006673(21)60125, (01)04056869006673(21)60085, (01)04056869006673(21)60113, (01)04056869006673(21)160027, (01)04056869006673(21)160012, (01)04056869006673(21)160016, (01)04056869006673(21)160032, (01)04056869006673(21)160013, (01)04056869006673(21)160014, (01)04056869006673(21)160018, (01)04056869006673(21)160031, (01)04056869006673(21)160011, (01)04056869006673(21)160015, (01)04056869006673(21)60054, (01)04056869006673(21)160037, (01)04056869006673(21)160034, (01)04056869006673(21)60063, (01)04056869006673(21)60079, (01)04056869006673(21)160008, (01)04056869006673(21)60110, (01)04056869006673(21)60124, (01)04056869006673(21)160041. Serial Numbers: 60060, 160040, 160028, 160021, 60108, 60121, 160019, 60091, 160020, 160043, 60062, 60061, 160029, 160038, 60086, 60126, 60047, 160036, 160003, 160042, 160024, 60092, 160035, 60102, 160039, 60112, 160030, 60099, 160007, 160001, 160006, 160009, 160033, 60053, 60070, 60101, 60125, 60085, 60113, 160027, 160012, 160016, 160032, 160013, 160014, 160018, 160031, 160011, 160015, 60054, 160037, 160034, 60063, 60079, 160008, 60110, 60124, 160041. Additional serial numbers added 2/25/2026: 60113.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Siemens Medical Solutions USA
All 796| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Artis icono ceiling recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis icono biplane recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis icono floor recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis icono ceiling recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis pheno recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | PA |
Other Other Medical Devices recalls
All 13,771| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ortho Aspiration Kit recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |