—#73824

Product

AXIOM Artis System dTC using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K052202
Affected lot / code info: Model number 7413078. Serial numbers: 46130, 46150, and 46205.

Why it was recalled

System may switch to emergency fluoroscopy mode.

Root cause (FDA determination)

Software design

Action the firm took

A Customer Safety Advisory Letter dated 8/20/08 was issued with Update Instructions AX045/08/S. The letter informed the customer of the potential issue and provided instruction to avoid its occurrence. A software update (VB31E) was released to correct the issue.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution including states of AR, CA, CO, FL, IA, IL, IN, KS, KY, MI, NY, TX, VA, and WY.

Timeline

Recall initiated: 2008-08-25
Posted by FDA: 2008-12-09
Terminated: 2010-01-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73824. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.