PlainRecalls
FDA Devices Moderate Class II Terminated

Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis 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 Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, mul

Reported: August 22, 2018 Initiated: June 22, 2018 #Z-2747-2018

Product Description

Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis 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 Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

Reason for Recall

Potential hardware issue which may cause thermal effects and possible damage to system parts.

Details

Units Affected
605 units in total
Distribution
US Nationwide Distribution
Location
Malvern, PA

Frequently Asked Questions

What product was recalled? ▼
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis 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 Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 605 units in total.
Why was this product recalled? ▼
Potential hardware issue which may cause thermal effects and possible damage to system parts.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 22, 2018. Severity: Moderate. Recall number: Z-2747-2018.

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