Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94299

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

Open FDA event record

Event summary

Timeline bucket
March 21, 2024
Product types
Device
Classifications
Class II
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

Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego- 10848283 Artis Q.zen floor- 10848353 Artis Q.zen ceiling- 10848354 Artis Q.zen biplane- 10848355 Artis zee floor MN- 10094142 Artis zee biplane MN- 10094143

Z-1598-2024
Recall number
Z-1598-2024
Initiated
March 21, 2024
Classification
Class II
Status
Ongoing
Quantity
583 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot be operated normally, may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot be operated normally, may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

Code information

Model/UDI-DI: Artis zee floor- 4056869010045 Artis zee ceiling- 4056869010052 Artis zee multi-purpose- 4056869010076 Artis zee biplane- 4056869010069 Artis zee floor MN- 4056869010090 Artis zee biplane MN- 4056869010106 Artis zeego- 4056869010083 Artis Q floor- 4056869009971 Artis Q ceiling- 4056869009988 Artis Q biplane- 4056869009995 Artis Q zeego- 4056869010007 Artis Q.zen floor- 4056869010014 Artis Q.zen ceiling- 4056869010021 Artis Q.zen biplane- 4056869010038

Distribution pattern

US Nationwide distribution.

Field note

Send feedback

We'll only use this to respond to your feedback.