—#91442

Product

Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355. Intended for x-ray, angiographic use.

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K021021
Affected lot / code info: Model Numbers: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717 and 7728392.

Why it was recalled

sporadic malfunctions of the Artis Systems with Motor Controller caused by tolerances on electronic parts that might increase during the lifetime of the system.

Root cause (FDA determination)

Device Design

Action the firm took

Siemens issued an "Urgent Field Safety Notice" to consignees describing the affected device instructing users to contact the recalling firm's service organization to schedule maintenance. For further information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-3237.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2010-04-12
Posted by FDA: 2010-05-28
Terminated: 2013-04-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91442. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.