EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in v

FDA device recall Z-2242-2012 · posted 2012-08-22 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

When using the EasyLink Quality Control Package the system may not perform as intended for Multi-Rule QC violations [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions send with the Urgent Field Safety Notice. When this situation occurs, QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient

Action taken

Siemens sent an "URGENT FIELD SAFETY NOTICE" dated May 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Correction Effectiveness Check Form was attached for customers to complete and return via fax to 302-631-8467. Contact Siemens Technical Solutions Center at 800-441-9250 for questions regarding this notice.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

637

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Canada, France, Germany, Spain, Portugal, Italy, Japan, Norway, Australia, Austria, New Zealand, Belgium, Switzerland, Netherlands, Malaysi

Date initiated

2012-05-29

Date posted

2012-08-22

Date terminated

2014-04-10

Location

Newark, DE