—#94452

Product

AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755 Angiographic X-ray System

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K021021
Affected lot / code info: Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755. Mulitple Serial Numbers per Distribution Listing

Why it was recalled

Sporadic system crash while Perivision is performed.

Root cause (FDA determination)

Software design

Action the firm took

Siemens issued an Urgent Field Safety Notice to all customers. The letter informed customers of the potential issues and provided additional information on the implemented resolution. To resolve the problem, a system update was to be installed on each affected system under Update Instructions AX054/10/S. For questions phone (610) 448-3237.

Recalling firm

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

Distribution

Distribution pattern: USA - Nationwide Distribution

Timeline

Recall initiated: 2010-09-09
Posted by FDA: 2010-10-26
Terminated: 2012-09-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94452. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.