Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97845

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 01, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Siemens Medical Solutions USA, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

MAGNETOM Cima.X Upgrade. Model Number: 11689304.

Z-0431-2026
Recall number
Z-0431-2026
Initiated
October 01, 2025
Classification
Class I
Status
Ongoing
Quantity
4 system (1 US; 3 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, 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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, 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.

Code information

Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.

Distribution pattern

US distribution to California. International distribution to Australia, Germany, Great Britian.