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Terminated

Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray System, Model Number: 4466033. Indended use: X-Ray, Fluoroscopic, Image-intensified.

FDA Recall Z-0189-2010 · Posted 2009-11-12

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2009-09-23
Date Terminated2010-01-12
Product Quantity14 units

Reason for Recall

possible injury to hand/fingers

Firm Action

Siemens Medical Solutions USA, Inc. issued a "Customer Safety Advisory Notice" dated September 11, 2009 to inform customers of the potential hazard to patients when using the Siregraph CF system. For further information, contact Siemens at 1-610-448-4500.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution -- FL, IL, MI, PA and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K960266SIREGRAPH CFSiemens Medical Solutions USA, Inc. · 1996-03-11

Official Source

View FDA Recall →

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

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