—#186134

Product

Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K193326
Affected lot / code info: ARTIS Icono biplane- 11327600 ARTIS Icono floor- 11327700

Why it was recalled

Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.

Root cause (FDA determination)

Component design/selection

Action the firm took

On 2/26/2021, Siemens issued an Urgent Medical Device Correction notice to in inform customers of a possible hazard to patients, operators, or other persons and equipment due to a hardware error which affects ARTIS icono /pheno systems in combination with imaging system UPS (Uninterrupted Power Supply) option. This potential hardware issue has no influence on the previous treatment/diagnosis of patients. However, in case of error, planned procedures may have to be terminated and performed on an alternative x-ray system. Based on our investigation, you can continue to safely use your system.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: US Nationwide distribution in the states of MI, KY, TX.

Timeline

Recall initiated: 2021-02-26
Terminated: 2021-08-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186134. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.