Z-1598-2024 Class II Ongoing
FDA device recall Z-1598-2024 was initiated by Siemens Medical Solutions USA, Inc on Mar 21, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 583 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 24, 2024
- Initiation Date
- Mar 21, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 583 units
Product Description
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
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
Distribution Pattern
US Nationwide distribution.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1598-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026