Food, drugs, devices › Siemens Medical Solutions USA, Inc
Device recall: Biograph mMR. Model Number: 10433372.
FDA enforcement event 97530 is a device recall by Siemens Medical Solutions USA, Inc of Malvern, PA, initiated 28 Aug 2025 and classified Class I, with 15 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 13% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Siemens Medical Solutions USA, Inc has 400 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Siemens Medical Solutions USA, Inc, Malvern, PA.
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…"
Distribution
"Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2654-2025 | Biograph mMR. Model Number: 10433372. | 27 units | Class I | Ongoing | 8 Oct 2025 |
| Z-2655-2025 | BIOGRAPH One (DE). Model Number: 11689172. | 1 unit | Class I | Ongoing | 8 Oct 2025 |
| Z-2656-2025 | MAGNETOM Cima.X (DE). Model Number: 11647158. | 22 units | Class I | Ongoing | 8 Oct 2025 |
| Z-2657-2025 | MAGNETOM Connectom.X. Model Number: 11371480. | 1 unit | Class I | Ongoing | 8 Oct 2025 |
| Z-2658-2025 | MAGNETOM Lumina (DE). Model Number: 11344916. | 130 units | Class I | Ongoing | 8 Oct 2025 |
| Z-2659-2025 | MAGNETOM Prisma. Model Number: 10849582. | 101 units | Class I | Ongoing | 8 Oct 2025 |
| Z-2660-2025 | MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560. | 586 units | Class I | Ongoing | 8 Oct 2025 |
| Z-2661-2025 | MAGNETOM Skyra fit. Model Number: 10849580. | 56 units | Class I | Ongoing | 8 Oct 2025 |
| Z-2662-2025 | MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217. | 39 units | Class I | Ongoing | 8 Oct 2025 |
| Z-2663-2025 | MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588. | 3 units | Class I | Ongoing | 8 Oct 2025 |
| Z-2664-2025 | MAGNETOM Verio. Model Number: 10276755. | 154 units | Class I | Ongoing | 8 Oct 2025 |
| Z-2665-2025 | MAGNETOM Verio Dot. Model Number: 10684333. | 59 units | Class I | Ongoing | 8 Oct 2025 |
| Z-2666-2025 | MAGNETOM Verio Dot Upgrade. Model Number: 10684334. | 78 units | Class I | Ongoing | 8 Oct 2025 |
| Z-2667-2025 | MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560. | 498 units | Class I | Ongoing | 8 Oct 2025 |
| Z-2668-2025 | MAGNETOM Vida Fit. Model Number: 11410481. | 41 units | Class I | Ongoing | 8 Oct 2025 |
Context
Other enforcement events for Siemens Medical Solutions USA, Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 Jun 2026 | ARTIS icono ceiling. Model Number: 11328100. | Device | Class II | 1 |
| 20 May 2026 | ARTIS icono biplane. Model Number: 11327600. | Device | Class II | 3 |
| 12 Mar 2026 | ARTIS Pheno VE30A and VE40A, Model 10849000 | Device | Class II | 1 |
| 10 Mar 2026 | ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. | Device | Class II | 1 |
| 9 Mar 2026 | ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system | Device | Class II | 2 |
| 29 Dec 2025 | Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Vers | Device | Class II | 2 |
| 19 Dec 2025 | SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS | Device | Class II | 4 |
| 5 Dec 2025 | LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 | Device | Class II | 1 |
| 24 Oct 2025 | MAMMOMAT Revelation; | Device | Class II | 3 |
| 1 Oct 2025 | MAGNETOM Cima.X Upgrade. Model Number: 11689304. | Device | Class I | 1 |
All 400 events for Siemens Medical Solutions USA, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.