—#139160

Product

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.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123529
Affected lot / code info: Model Number of device: 10848282 10848281 10848355 10848354 serial numbers: 121006 121013 109016 121011 123008 123003 123011 121014 109011 121004 121018 121036 121012 109015 109009 121019 121010 121015 121016 109007 111000 121020 121009 121056 121057 109021 121008 109020 109027 109010 123010 121041

Why it was 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.

Root cause (FDA determination)

Device Design

Action the firm took

A customer safety notice, dated June 29, 2015, was sent to direct accounts to alert them about the issue and that Siemens' service organization will be contacting them to perform the corrective action.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: US Nationwide

Timeline

Recall initiated: 2015-06-29
Posted by FDA: 2015-08-05
Terminated: 2016-12-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139160. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.