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User Defined Method Flex Assignment/Siemens Dimension Vista… recallZ-0851-2014 · Siemens Healthcare Diagnostics, Inc. · initiated Oct 7, 2013

Class II Terminated All recalls posted in January 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-0851-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 7, 2013
Posted by the FDA
Jan 28, 2014
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
2038
Product code
JJE
FDA submissions
K051087
Distribution
USA (nationwide) Distribution including Puerto Rico.

Product description

User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.

Code information (models, lots, serial numbers)

Material numbers 10284473, 10488224, 10444801, and 10444802.

Other devices under the same FDA submission

4 devices cleared under K051087 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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