Z-3099-2017Class II
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of...
Siemens Medical Solutions USA, Inc. / initiated 2016-02-18 / Terminated
Siemens Medical Solutions USA, Inc began a recall of Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and... on . FDA classified it as Class II and gives the reason as "Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in...". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-3099-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen 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. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
- Product code
- IZI System, X-Ray, Angiographic
- Reason for recall
- Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.
- FDA root cause
- Unknown/Undetermined by firm
- Action
- Siemens mailed a Customer Safety Advisory Notice (CSAN) dated February 18, 2016, to affected customers informing them that their service organization will contact them to arrange a date to perform the corrective action (replacement of affected plastic couplings to prevent fluid leaks). Customers were advised to contact Siemens service organization for an appointment to schedule the work For questions regarding this recall call 610-.448-6461.
- Quantity in commerce
- 986 units in USA
- Distribution
- Nationwide Distribution
- Product codes and lots
- Artis zeego.Q - Serial number: 117108 117001 117023 117021 117029 117006 117112 117034 117020 117018 117030 117026 117100 117111 117024 117113 117040 117041 117114 117014 117009
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-3088-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3089-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3090-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3091-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3092-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3093-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3094-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3095-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3096-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3097-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3098-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3099-2017 | Class II | Terminated | Voluntary: Firm initiated |
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