MAGNETOM SpectraRecalls & reported problems across all models
Siemens Shenzhen Magnetic Resonance Ltd. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one MAGNETOM Spectra model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 2 models of MAGNETOM Spectra by Siemens Shenzhen Magnetic Resonance Ltd. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Mar 25, 2022 and Dec 11, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Explosion” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
MAGNETOM Spectra recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 28, 2025Open, Classified
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.
Z-2663-2025 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported MAGNETOM Spectra problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Explosion1
Patient problems
- Blister1
- No Clinical Signs, Symptoms or Conditions1
MAGNETOM Spectra models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MAGNETOM Spectra 10655588System, nuclear magnetic resonance imaging1 recall1 report
- MAGNETOM Spectra 10837643Coil, magnetic resonance, specialty1 recall1 report
Recent MAGNETOM Spectra adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2023Explosion; Explosion
SIEMENS HEALTHINEERS WAS INFORMED THAT THE MAGNETOM SPECTRA MAGNET QUENCHED UNEXPECTEDLY. HELIUM WAS RELEASED WITHIN THE EXAMINATION ROOM VIA THE PUMP-OUT/DROP-FF PORT. THE PRESSURE BUILDUP WAS SO INTENSE THAT IT CAUSED EXTENSIVE DAMAGE TO THE EXAMINATION ROOM. THE RF DOOR WAS BLOWN OPEN AND THE FLOOR TILES, CEILING, AND WALL WERE DAMAGED. IT IS NOT KNOWN WHY THE MAGNET QUENCHED. THE SYSTEM REPORTEDLY DISPLAYED A MAGNET ERROR PRIOR TO THE EVENT. FORTUNATELY, THERE WAS NO REPORT OF INJURY TO STAFF OR PATIENT BECAUSE OF THIS EVENT. ALTHOUGH THERE WAS NO REPORT OF INJURY, IN A WORST-CASE SCENARIO, SERIOUS INJURY COULD RESULT IF THE ISSUE WERE TO RECUR. SIEMENS HEALTHINEERS HAS REQUESTED ADDITIONAL INFORMATION REGARDING THIS EVENT. THE ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT AND IS PENDING RECEIPT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18300022 ↗InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED FOLLOWING EXAMINATION ON THE MAGNETOM SPECTRA MR SYSTEM. FOLLOWING A SPINE SCAN, THE PATIENT COMPLAINED OF BLISTERS. THE PATIENT WAS TREATED WITH A CREAM AND NO FURTHER IMPACT TO THE PATIENT IS KNOWN. AT THIS TIME, NO SYSTEM MALFUNCTION HAS BEEN IDENTIFIED, HOWEVER, SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.
Patient problems: Blister
MAUDE report 13900345 ↗
Other Siemens Shenzhen Magnetic Resonance Ltd. products
All Siemens Shenzhen Magnetic Resonance Ltd. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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