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FDA Recall Z-1491-2017 · Posted None
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2017-02-14
Date Terminated2017-12-18
Product Quantity80 systems
Reason for Recall
Software update
Firm Action
Siemens mailed an Customer Information Letter on 02/15/2017 to affected customers to inform them of a software update they plan to implement to reduce risk of collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table, using the SIMTEC-Auto Field Sequence Option.
Root Cause
Software design
Distribution Pattern
Distributed throughout the United States
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.