PlainRecalls
FDA Devices Moderate Class II Terminated

Artis Q systems; 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

Reported: August 12, 2015 Initiated: June 29, 2015 #Z-2341-2015

Product Description

Artis Q systems; 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

Reason for Recall

The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.

Details

Units Affected
N/A
Distribution
US Nationwide
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Artis Q systems; 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: N/A.
Why was this product recalled?
The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 12, 2015. Severity: Moderate. Recall number: Z-2341-2015.