—#71400

Product

Impression Therapist 3rd party V&R equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7345429 Medical charged-particle radiation therapy system.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060226
Affected lot / code info: Serial numbers associated with RTT2.0 and RTT2.1

Why it was recalled

Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.

Root cause (FDA determination)

Software design

Action the firm took

Service calibration inspection/correction Update instructions TH038/07/S was issued on 11/06/2007 to all customers. The instructions identified the affected products, stated the reason for the update, and listed the steps to update the software. Customer notification was also issued. Software patch planned for release in June 2008.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2007-11-06
Posted by FDA: 2008-10-16
Terminated: 2010-12-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71400. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.