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Recall Observatory FDA recall evidence

Device product

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

March 21, 2024

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 94299
Status
Ongoing
Classification
Class II
Quantity
583 units
Official record key
device-enforcement:Z-1598-2024

Official wording

Reason: 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.

Derived failure modes

  • 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