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VersaCell X3 Solution and VersaCell X3 Expansion Pack, a… recallZ-1832-2014 · Siemens Medical Solutions Diagnostics · initiated Apr 25, 2014

Class III Terminated All recalls posted in June 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 Medical Solutions Diagnostics 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

The keyboard and monitor may not be properly secured to the monitor arm.

FDA root cause category: Device Design

What the company is doing

Siemen's Healthcare Diagnostics sent an Urgent Medical Device Correction letter dated April 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return teh Field Correction Effectiveness Check form attached to the letter within 30 days by fax to 302-631-7597. Inspect the monitor, keyboard and bracket assembly. If the screw and washer assembly is secure as shown in Figure 1, the monitor and keyboard assembly is safe to use. After making adjustments or repositioning the monitor, keyboard and bracket assembly, inspect the screw adn washer to ensure it is ssecure as shown in Figure 1. If there is a gap between the underside of the monitor support bracket and cylindrical mounting feature as shown in Figure 2, contact your Siemens technical support representative to schedule a service visit as soon as possible. Front load and manage samples directly on the connected instruments until your Siemens technical support representative addresses the issue. Customers were instructed to retain the letter with their laboratory records, and forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding this recall call 877-229-3711.

Recall details

Recall number
Z-1832-2014
Recall class
Class III
Status
Terminated
Initiated by the company
Apr 25, 2014
Posted by the FDA
Jun 19, 2014
Recalling firm
Siemens Medical Solutions Diagnostics
Quantity
19 units
Product code
LXG
FDA submissions
K970227
Distribution
Worldwide Distribution - USA including Iowa and New York and Internationally to Canada, Chile, France, India, Italy, Malaysia, Peru, Korea, and the United Kingdom.

Product description

VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.

Code information (models, lots, serial numbers)

Siemens Material Numbers: Instrument 10793839, Expansion Pack 10913528

Other devices under the same FDA submission

3 devices cleared under K970227 — 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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