User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5

FDA device recall Z-0851-2014 · posted 2014-01-28 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use the incorrect Flex Cartridge to process the user defined method.

Action taken

Siemens sent a Urgent Medical Device Correction letter dated October 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please use the following actions if using Vista SW Versions 3.5.1 and below to prevent the issue from occurring: 1. When assigning a User Defined (EMPTY) Flex, use the Advanced Inventory Screen per the Operators Guide. 2. Verify that EMPTY Flex is no longer listed in the inventory before proceeding with any testing. 3. If the EMPTY Flex is still listed in the inventory, contact your Siemens Customer Care Center - Technical Solutions for assistance. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Discuss the content of this letter with your Medical Director. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center - Technical Solutions at (800-441-9250) or your local Siemens technical support representative.

Root cause

Software design

Status

Terminated

Product code

JJE

Quantity affected

2038

Distribution

USA (nationwide) Distribution including Puerto Rico.

Date initiated

2013-10-07

Date posted

2014-01-28

Date terminated

2014-08-27

Location

Newark, DE

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