VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to

FDA device recall Z-1832-2014 · posted 2014-06-19 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions Diagnostics

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

LXG

Quantity affected

19 units

Distribution

Worldwide Distribution - USA including Iowa and New York and Internationally to Canada, Chile, France, India, Italy, Malaysia, Peru, Korea, and the United Kingdom.

Date initiated

2014-04-25

Date posted

2014-06-19

Date terminated

2015-04-16

Location

Flanders, NJ

Related 510(k) clearances