FDA Device Recall Z-0121-2011: Siemens Healthcare Diagnostics, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0121-2011.

Recall Res Number

Z-0121-2011

Recalling Firm / Manufacturer

Siemens Healthcare Diagnostics, Inc.

FEI Number

2517506

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2010-07-23

Date Posted

2010-10-21

Date Terminated

2013-03-19

Product Code

JJE

Event Number

56484

Product Quantity

Product Description EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.

Reason for Recall the EasyLink QCFIRST custom rule does not operate as intended.

Action Details Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice dated July 2010 to all customers that have the EasyLink QCFIRST custom rule installed. This Urgent Field Safety Notice included information on the problem and confirmed that a Siemens representative would contact them to facilitate the removal of the rule from the EasyLink System. For questions contact the Siemens Healthcare Diagnostics Technical Solution Center at 1-800-441-9250.

Distribution Pattern Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MO, MS, NC, NH, NJ, NM, NY, OH, OR, PA, TX, VA, WA, WI, and WY and the country of Canada.

Code Information / Serial Numbers Part # 1000034805

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Medical Device Recall: Z-0121-2011

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer