FDAFDA · Food and drugs·Recall number Z-2658-2025
MAGNETOM Lumina (DE). Model Number: 11344916.
Published October 8, 2025 · Recall initiated: August 28, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- 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.
- Lot
- Model Number: 11344916. UDI Numbers: (01)04056869230740(21)196458, (01)04056869230740(21)196591, (01)04056869230740(21)196655, (01)04056869230740(21)196355, (01)04056869230740(21)196733, (01)04056869230740(21)196668, (01)04056869230740(21)196477, (01)04056869230740(21)196343, (01)04056869230740(21)196553, (01)04056869230740(21)196519, (01)04056869230740(21)196366, (01)04056869230740(21)196782, (01)04056869230740(21)196617, (01)04056869230740(21)196684, (01)04056869230740(21)196502, (01)04056869230740(21)196539, (01)04056869230740(21)196280, (01)04056869230740(21)196626, (01)04056869230740(21)196511, (01)04056869230740(21)196643, (01)04056869230740(21)196796, (01)04056869230740(21)196551, (01)04056869230740(21)196495, (01)04056869230740(21)196741, (01)04056869230740(21)196621, (01)04056869230740(21)196611, (01)04056869230740(21)196544, (01)04056869230740(21)196724, (01)04056869230740(21)196776, (01)04056869230740(21)196752, (01)04056869230740(21)196372, (01)04056869230740(21)196350, (01)04056869230740(21)196841, (01)04056869230740(21)196252, (01)04056869230740(21)196508, (01)04056869230740(21)196332, (01)04056869230740(21)196496, (01)04056869230740(21)196753, (01)04056869230740(21)196375, (01)04056869230740(21)196738, (01)04056869230740(21)196260, (01)04056869230740(21)196470, (01)04056869230740(21)196765, (01)04056869230740(21)196334, (01)04056869230740(21)196288, (01)04056869230740(21)196409, (01)04056869230740(21)196737, (01)04056869230740(21)196286, (01)04056869230740(21)196604, (01)04056869230740(21)196446, (01)04056869230740(21)196362, (01)04056869230740(21)196518, (01)04056869230740(21)196619, (01)04056869230740(21)196450, (01)04056869230740(21)196678, (01)04056869230740(21)196349, (01)04056869230740(21)196261, (01)04056869230740(21)196415, (01)04056869230740(21)196386, (01)04056869230740(21)196391, (01)04056869230740(21)196537, (01)04056869230740(21)196649, (01)04056869230740(21)196411, (01)04056869230740(21)196353, (01)04056869230740(21)196629, (01)04056869230740(21)196403, (01)04056869230740(21)196529, (01)04056869230740(21)196622, (01)04056869230740(21)196414, (01)04056869230740(21)196778, (01)04056869230740(21)196308, (01)04056869230740(21)196768, (01)04056869230740(21)196791, (01)04056869230740(21)196832, (01)04056869230740(21)196606, (01)04056869230740(21)196240, (01)04056869230740(21)196730, (01)04056869230740(21)196360, (01)04056869230740(21)196466, (01)04056869230740(21)196831, (01)04056869230740(21)196789, (01)04056869230740(21)196780, (01)04056869230740(21)196779, (01)04056869230740(21)196405, (01)04056869230740(21)196625, (01)04056869230740(21)196376, (01)04056869230740(21)196703, (01)04056869230740(21)196828, (01)04056869230740(21)196522, (01)04056869230740(21)196570, (01)04056869230740(21)196422, (01)04056869230740(21)196800, (01)04056869230740(21)196775, (01)04056869230740(21)196795, (01)04056869230740(21)196514, (01)04056869230740(21)196565, (01)04056869230740(21)196586, (01)04056869230740(21)196451, (01)04056869230740(21)196525, (01)04056869230740(21)196326, (01)04056869230740(21)196463, (01)04056869230740(21)196331, (01)04056869230740(21)196413, (01)04056869230740(21)196634, (01)04056869230740(21)196746, (01)04056869230740(21)196359, (01)04056869230740(21)196461, (01)04056869230740(21)196330, (01)04056869230740(21)196750, (01)04056869230740(21)196354, (01)04056869230740(21)196557, (01)04056869230740(21)196321, (01)04056869230740(21)196688, (01)04056869230740(21)196818, (01)04056869230740(21)196338, (01)04056869230740(21)196772, (01)04056869230740(21)196472, (01)04056869230740(21)196651, (01)04056869230740(21)196440, (01)04056869230740(21)196687, (01)04056869230740(21)196509, (01)04056869230740(21)196799, (01)04056869230740(21)196549, (01)04056869230740(21)196717, (01)04056869230740(21)196398, (01)04056869230740(21)196367, (01)04056869230740(21)196823, (01)04056869230740(21)196830, (01)04056869230740(21)196464, (01)04056869230740(21)196815. Serial Numbers: 196458, 196591, 196655, 196355, 196733, 196668,
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.