Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data

FDA device recall Z-2561-2014 · posted 2014-09-01 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

May not perform as intended under certain conditions, causing the release of results to the Laboratory Information System (LIS) that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.

Action taken

Siemens issued an Urgent Medical Device Correction (UMDC) letter on August 13, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review this letter in its entirety and ensure that all operators understand the information presented. The issues described are specific to the features listed in the letter.. If the laboratory is not using a particular feature, then they are not affected by the issues described for that feature. For questions contact your Siemens Customer Care Center or your local Siemens technical support representative.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

1347

Distribution

US Nationwide Distribution

Date initiated

2013-08-13

Date posted

2014-09-01

Date terminated

2014-12-02

Location

Newark, DE