FDA Device

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

Hazard

Sporadic system crash while Perivision is performed.

What You Should Do

Remedy

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.

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Products

AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755 Angiographic X-ray System
Brand
Siemens Medical Solutions USA, Inc
UPC
Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755. Mulitple Serial Numbers per Distribution Listing

Units Affected

286 units

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