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MAGNETOM Vida recallZ-2667-2025 · Siemens Medical Solutions USA, Inc · initiated Aug 28, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Under Investigation by firm

What the company is doing

Siemens Healthcare notified consignees on about 08/28/2025 via letter. Consignees were informed that Siemens Customer Service Organization will conduct an inspection of affected units to address the issue. If customers identify issues, they are cautioned to not reboot the system, to call their local Siemens Healthineers service organization, and grant access to the system. Siemens will inspect devices and perform a correction, if needed. Consignees were also instructed to ensure all users or customers are notified of the issue and to maintain the Customer Safety Advisory Notice. Consignees were also requested to confirm receipt and acknowledgement of the notification. Siemens expanded the recall and notified consignees on about 10/01/2025 via letter. These notifications included the same information as initially sent to consignees. A follow up communication was sent to consignees on about 10/15/2025 via letter. This informed users of further details and additional necessary safety actions. If a specific "Magnent Supervision" error message appears on the host computer, no further scans can be performed, and you are requested to: not reboot the system, remove the patient from the system, lock/secure all access to the scanning room with the system remaining energized at field, post a DO NOT USE notice on or near the device, and call the Siemens Healthineers service organization. In addition, Siemens reminded users that the Magnet Stop button is only intended for emergencies. DO NOT initiate a manual quench of the magnet unless there is an emergency. Ensure all designated emergency exit routes remain unobstructed and are marked. Consignees were also instructed to ensure all users or customers are notified of the issue, to maintain the Customer Safety Advisory Notice is retained in product related records, to confirm receipt and acknowledgement of the notification, and if the affected system is no longer in the consignee's possession, notify the new owner. ***Updat

Recall details

Recall number
Z-2667-2025
Status
Open, Classified
Initiated by the company
Aug 28, 2025
Posted by the FDA
Sep 30, 2025
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
498 units
Product code
LNH
FDA submissions
K170396, K231560
Distribution
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.

Product description

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

Code information (models, lots, serial numbers)

Show the full code information (19k characters)

Model Number: 11060815. UDI Numbers: (01)04056869039176(21)176636, (01)04056869039176(21)177211, (01)04056869039176(21)175728, (01)04056869039176(21)175685, (01)04056869039176(21)175851, (01)04056869039176(21)175768, (01)04056869039176(21)177298, (01)04056869039176(21)177295, (01)04056869039176(21)176756, (01)04056869039176(21)175754, (01)04056869039176(21)177349, (01)04056869039176(21)176757, (01)04056869039176(21)177232, (01)04056869039176(21)175935, (01)04056869039176(21)176967, (01)04056869039176(21)175741, (01)04056869039176(21)177052, (01)04056869039176(21)176060, (01)04056869039176(21)176371, (01)04056869039176(21)177012, (01)04056869039176(21)177146, (01)04056869039176(21)175770, (01)04056869039176(21)176375, (01)04056869039176(21)176122, (01)04056869039176(21)176308, (01)04056869039176(21)175669, (01)04056869039176(21)176212, (01)04056869039176(21)176755, (01)04056869039176(21)176781, (01)04056869039176(21)176302, (01)04056869039176(21)176036, (01)04056869039176(21)175766, 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(01)04056869039176(21)177230, (01)04056869039176(21)177231, (01)04056869039176(21)176852, (01)04056869039176(21)176502, (01)04056869039176(21)176282, (01)04056869039176(21)175881, (01)04056869039176(21)176912, (01)04056869039176(21)176058, (01)04056869039176(21)175738, (01)04056869039176(21)175657, (01)04056869039176(21)175705, (01)04056869039176(21)175758, (01)04056869039176(21)177054, (01)04056869039176(21)177386, (01)04056869039176(21)176754, (01)04056869039176(21)176925, (01)04056869039176(21)177255, (01)04056869039176(21)176457, (01)04056869039176(21)177256, (01)04056869039176(21)177127, (01)04056869039176(21)175614, (01)04056869039176(21)177164, (01)04056869039176(21)176486, (01)04056869039176(21)176438, (01)04056869039176(21)176157, (01)04056869039176(21)176995, (01)04056869039176(21)177323, (01)04056869039176(21)176410, (01)04056869039176(21)176680, (01)04056869039176(21)176518, (01)04056869039176(21)175941, (01)04056869039176(21)175618, (01)04056869039176(21)176364, (01)04056869039176(21)175801, (01)04056869039176(21)175822, (01)04056869039176(21)176040, (01)04056869039176(21)175643. Serial Numbers: 176636, 177211, 175728, 175685, 175851, 175768, 177298, 177295, 176756, 175754, 177349, 176757, 177232, 175935, 176967, 175741, 177052, 176060, 176371, 177012, 177146, 175770, 176375, 176122, 176308, 175669, 176212, 176755, 176781, 176302, 176036, 175766, 176825, 177151, 176087, 176771, 177299, 176451, 177352, 177354, 176779, 175870, 175838, 175692, 177359, 177119, 175977, 176037, 177244, 176686, 175831, 177096, 176660, 177034, 176639, 176397, 175805, 176358, 176293, 176118, 175681, 177088, 177035, 176093, 176189, 177337, 177333, 176094, 176736, 177105, 177007, 175787, 177381, 176027, 176340, 177144, 176258, 176363, 176561, 176665, 176577, 176572, 176559, 176696, 176452, 176081, 175853, 175893, 177033, 177392, 177116, 177124, 175897, 175883, 177329, 176567, 175640, 176033, 176316, 176529, 176219, 176254, 176865, 176709, 176059, 175829, 175706, 176635, 175903, 176374, 176217, 176832, 175834, 175655, 175660, 176630, 177258, 177162, 176661, 177371, 176829, 175907, 176956, 177213, 176570, 176532, 177257, 177262, 176319, 175850, 176332, 176096, 176492, 177265, 176654, 177332, 176092, 177356, 176288, 175765, 176350, 176751, 176038, 176437, 177319, 176086, 177347, 175976, 177125, 176391, 176828, 176814, 176030, 177086, 176813, 177118, 176433, 176594, 177159, 175825, 176414, 177178, 177238, 177123, 176962, 176211, 177102, 176843, 176102, 177366, 176000, 176483, 176048, 177209, 176906, 175734, 175964, 175682, 175650, 175651, 175625, 175656, 175875, 175843, 175721, 176002, 177324, 176831, 177402, 176459, 176658, 176101, 176203, 175676, 175866, 177309, 176084, 177312, 175695, 176130, 175661, 175920, 175737, 175847, 177289, 177283, 177293, 175819, 176948, 176637, 176176, 177143, 176519, 176733, 177214, 176607, 176238, 175849, 176261, 177346, 177345, 176667, 177210, 175979, 176328, 176333, 176336, 177237, 177136, 176811, 176312, 175915, 176537, 177398, 177149, 177216, 177217, 175700, 176137, 175639, 175922, 175873, 175774, 177276, 176186, 176573, 176069, 176341, 176449, 176420, 176677, 176874, 176969, 176652, 176927, 175740, 177339, 175912, 176168, 175982, 176508, 176091, 175701, 175624, 175671, 175673, 175672, 176011, 176139, 176010, 176259, 176877, 176880, 176876, 176159, 176683, 176526, 176958, 177203, 177383, 175616, 177155, 175954, 176676, 175914, 176544, 177104, 177234, 176393, 175803, 176287, 177160, 176299, 176788, 177331, 177253, 175615, 176239, 177170, 177336, 177334, 176732, 177303, 175716, 175876, 176004, 177184, 176218, 175634, 177181, 175990, 176405, 177150, 177072, 176524, 177361, 176119, 176586, 177374, 176326, 176868, 176475, 175830, 175611, 175820, 177259, 176169, 177205, 177286, 176546, 176550, 175810, 177384, 176354, 176246, 176204, 176465, 177109, 176021, 175633, 176020, 177061, 176127, 176888, 176596, 177318, 175761, 176146, 177031, 176184, 177397, 176348, 176251, 176691, 175731, 177348, 177011, 176533, 176555, 177107, 175760, 176120, 176083, 176229, 177363, 175869, 177292, 177172, 177173, 176731, 176194, 176248, 175839, 175986, 175663, 176161, 176939, 176700, 176271, 176930, 177279, 176563, 176837, 176849, 177368, 177380, 176790, 176054, 176445, 175872, 175777, 176560, 177133, 176651, 176377, 176376, 176196, 176195, 175647, 175807, 175627, 175629, 176068, 176064, 175816, 175814, 177275, 177273, 176450, 176578, 175772, 175779, 177278, 177270, 177267, 177281, 176053, 177239, 176953, 175786, 176815, 175894, 176735, 176994, 177055, 175993, 176057, 175775, 177032, 176512, 175691, 176545, 177220, 177037, 177285, 176944, 176047, 177145, 175965, 175635, 175746, 176072, 175654, 176294, 176089, 176085, 176522, 177189, 175689, 177338, 176178, 176541, 176759, 176142, 175919, 177098, 176202, 176689, 177280, 177229, 176548, 177230, 177231, 176852, 176502, 176282, 175881, 176912, 176058, 175738, 175657, 175705, 175758, 177054, 177386, 176754, 176925, 177255, 176457, 177256, 177127, 175614, 177164, 176486, 176438, 176157, 176995, 177323, 176410, 176680, 176518, 175941, 175618, 176364, 175801, 175822, 176040, 175643.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

5 devices cleared under K170396, K231560 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97530).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page