Z-2658-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 8, 2025
- Initiation Date
- August 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 130 units
Product Description
MAGNETOM Lumina (DE). Model Number: 11344916.
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.
Distribution Pattern
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.
Code Information
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, 196477, 196343, 196553, 196519, 196366, 196782, 196617, 196684, 196502, 196539, 196280, 196626, 196511, 196643, 196796, 196551, 196495, 196741, 196621, 196611, 196544, 196724, 196776, 196752, 196372, 196350, 196841, 196252, 196508, 196332, 196496, 196753, 196375, 196738, 196260, 196470, 196765, 196334, 196288, 196409, 196737, 196286, 196604, 196446, 196362, 196518, 196619, 196450, 196678, 196349, 196261, 196415, 196386, 196391, 196537, 196649, 196411, 196353, 196629, 196403, 196529, 196622, 196414, 196778, 196308, 196768, 196791, 196832, 196606, 196240, 196730, 196360, 196466, 196831, 196789, 196780, 196779, 196405, 196625, 196376, 196703, 196828, 196522, 196570, 196422, 196800, 196775, 196795, 196514, 196565, 196586, 196451, 196525, 196326, 196463, 196331, 196413, 196634, 196746, 196359, 196461, 196330, 196750, 196354, 196557, 196321, 196688, 196818, 196338, 196772, 196472, 196651, 196440, 196687, 196509, 196799, 196549, 196717, 196398, 196367, 196823, 196830, 196464, 196815.