SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE

FDA device recall Z-1041-2013 · posted 2013-04-02 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.

Action taken

Siemens Medical Solutions sent a Customer Information letter via mail to all affected customers. The letter identified the affected product, problem and provide instructions on the correction. Customers were instructed to include the Customer Information letter in the Owner Manual chapter "Safety Advisory Letters". 9-16-13 UPDATE: - Control Console SW 9.2.18 was released to support the rol-out 10/18/2013; Distribution of update instructions for TH017/13S and TH018/13S - Distribtuion of the Control Console SW 9.2.18 released

Root cause

Software design (manufacturing process)

Status

Terminated

Product code

IYE

Quantity affected

621 units (foreign account) in total

Distribution

Worldwide Distribution

Date initiated

0013-03-05

Date posted

2013-04-02

Date terminated

2014-08-28

Location

Martinez, CA

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