Home / Recalls / Siemens Medical Solutions USA, Inc / Z-0558-2019

Z-0558-2019 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-0558-2019 was initiated by Siemens Medical Solutions USA, Inc on Oct 26, 2018 and is designated Class II. Reason for recall: This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-ray tube. The Artis zee system may lose coolant due to a possible leakage in a hose of the cooling unit… The recall status is terminated (terminated May 12, 2020). Affected quantity: 64 (16 in US).

Recall Details

Product Type: Devices
Report Date: Dec 12, 2018
Initiation Date: Oct 26, 2018
Termination Date: May 12, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 64 (16 in US)

Product Description

Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Reason for Recall

This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-ray tube. The Artis zee system may lose coolant due to a possible leakage in a hose of the cooling unit in the X-ray tube. This will cause the X-ray tube not to be sufficiently cooled down. As a result, the system will display a message Tube hot, have a break . The X-ray will be blocked several minutes later and to prevent any damage to the machine the following message will be displayed NO XRAY, TUBE TOO HOT . This issue is very sporadic and may occur during an ongoing clinical procedure. Use of this product may have a potential impact on planned procedures as they may be delayed as well as in emergent cases, as clinical treatment may need to be terminated and transferred to a functioning system.

Distribution Pattern

US Distribution to states of: AR, CA, KS, KY, MD, MN, NM, OK, PA, RI, TX, and UT.

Code Information

Serial nos: 910045-09 911354-02 910045-19 908883-23 910045-15 910045-14 910045-25 908883-04 911354-25 908883-18 908883-11 910045-21 911354-26 908883-06 908883-02 911354-27

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0558-2019
openFDA file date: Oct 21, 2026
Loaded by RegDataLab: Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.