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Terminated

Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383.

FDA Recall Z-0138-2009 · Posted 2008-11-04

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2008-08-11
Date Terminated2012-12-21
Product Quantity66 units

Reason for Recall

Unintended movement of the system table and/or C arm.

Firm Action

Siemens Medical Solutions issued a letter to consignees on 8/11/2008 to inform them of the problem and a workaround should the issue occur prior to software revision.

Root Cause

Software design

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K940484COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEMSiemens Medical Solutions USA, Inc. · 1994-04-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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