PlainRecalls
FDA Devices Moderate Class II Completed

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000

Reported: July 4, 2018 Initiated: May 1, 2018 #Z-2283-2018

Product Description

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000

Reason for Recall

If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.

Details

Units Affected
39
Distribution
Healthcare facilities in AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, NE, NJ, NY, OH, TN, TX, UT, and VA. Foreign distribution to Australia, Austria, Belgium, Denmark, France, Germany, Italy, Japan, Kuwait, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled? ▼
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 39.
Why was this product recalled? ▼
If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 4, 2018. Severity: Moderate. Recall number: Z-2283-2018.

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