PRIMEVIEW 3i System 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8139847 Medical charged-particle radiation therapy system.
FDA Recall Z-0097-2009 · Posted 2008-10-16
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Date Initiated2007-11-06
Date Terminated2010-12-18
Product Quantity50 units
Reason for Recall
Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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