MAGNETOM Vida 11516152Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869260143), received between Apr 2, 2026 and Apr 2, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K192924, K203443, K231560, K252838); they may or may not involve this specific model.

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.

Recalls naming this device

1. Sep 1, 2023Class IIOpen, Classified

   In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense artifacts during head examinations only. These potential artifacts depend on the position of the headband, the amount of lubricating grease, as well as the sequence parameters used

   Z-2648-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2026Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A PATIENT INJURY ASSOCIATED WITH A MAGNETOM VIDA. IT WAS STATED THAT A PATIENT HAD A BURN MARK ON THE CHEST AT THE LOCATION OF AN ECG LEAD. SIEMEN HEALTHINEERS WAS INFORMED ON (B)(6) 2026 THAT THE PATIENT HAD REDNESS ON THE ABDOMEN AREA AND BLISTERS. THE PATIENT WAS REFERRED TO A PLASTIC SURGEON FOR SURGICAL INTERVENTION. THE PATIENT IS RECEIVING TREATMENT FROM THE HOSPITAL. AS OF THE DATE OF THIS REPORT, ADDITIONAL DETAILS REGARDING THE PATIENT'S CURRENT HEALTH STATUS WERE PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 24764426 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192924, K203443, K231560, K252838. One submission often covers many models, so check the product and lot details in each record.

• Z-2668-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Vida Fit. Model Number: 11410481.
• Z-2667-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
• Z-2659-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Prisma. Model Number: 10849582.
• Z-2660-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
• Z-2658-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Lumina (DE). Model Number: 11344916.
• Z-2447-2021 · Aug 16, 2021 · Open, Classified
  MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numbers: 11060815