inforMED
MalfunctionLMB

KINETDX NETWORK AND DWS, CWS, SWS WORKSTATIONS

Received Sep 10, 2002

Report MW1026138 · MDR key 416391

Device

Generic name

Pacs Network And Workstations

Manufacturer

Acuson Corp

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Nonstandard Device

Patient

*

Narrative

Description of Event or Problem

ACUSON CORP HAS A PICTURE COMMUNICATIONS AND ARCHIVING PRODUCT THAT DOES NOT HAVE A 510-K CLEARANCE.