🔍 RecallPedia

MAGNETOM Lumina (DE). Model Number: 11344916.

Class I - Dangerous
🏥 Medical Devices Recalled: August 28, 2025 Siemens Medical Solutions USA Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Siemens Medical Solutions USA, Inc
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

MAGNETOM Lumina (DE). Model Number: 11344916.

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2658-2025

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