MAGNETOM Spectra 10837643Recalls & reported problems
Siemens Shenzhen Magnetic Resonance Ltd. · MRI Scanner · Class 2
All models of MAGNETOM Spectra (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869006802), received between Dec 11, 2023 and Dec 11, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Explosion” (1 report).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Aug 28, 2025Class IOpen, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Explosion1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, 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 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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