Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. I

FDA device recall Z-2088-2013 · posted 2013-08-26 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a QC or calibrator product from a Vista vial. If two samples are dispensed into the same aliquot

Action taken

The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated June 2013 to its consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to take the following actions: 1) In the event that an instrument Reset is required for any reason, review the Current Activities Screen to determine if there are any pending QC or Calibration tests. 2) If there are no pending QC of Calibration tests, Rest the instrument or troubleshoot the instrument per the Operators Guide. 3) If there are pending QC or Calibration tests, restarting the software is necessary before resuming patient processing. Go to Operation -> Shutdown, confirm Yes, then on the blue console menu screen select start Vista. Consignees/customers were also asked to complete the Field Effectiveness Check form attached to the letter via fax to Siemens Healthcare Diagnostics at (302) 621-8467, and retain the letter with laboratory records, and forward the letter to those who may have received the product. If you have any questions, contact your Siemens Customer Care Center at (800-441-9250)-Technical Solutions or your local Siemens Technical Support representative.

Root cause

Software Design Change

Status

Terminated

Product code

JJE

Quantity affected

1937

Distribution

Worldwide distribution: US (nationwide) including PR and countries of: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New

Date initiated

2013-06-19

Date posted

2013-08-26

Date terminated

2014-08-27

Location

Newark, DE

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