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Terminated

Siemens Biograph mCt-X, model number 10248670. Medical Imaging Equipment.

FDA Recall Z-0162-2010 · Posted 2009-11-10

Recalling FirmSiemens Medical Solutions USA Inc.
Recall StatusTerminated
Product CodeKPS
Date Initiated2009-08-11
Date Terminated2009-12-22
Product Quantity3 units

Reason for Recall

In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly.

Firm Action

Siemens Medical Solutions USA, Inc. issued an "Urgent Field Correction - Recall" notice to consignees by letter dated September 3, 2009 informing them of the problem and that a Siemens service representative will be in contact shortly to service the affected product. For further information, contact Siemens at 1-800-888-7436.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- United States (IL and OH), Germany, France and Hong Kong.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060631BIOGRAPH 64 AND BIOGRAPH 40Siemens Medical Solutions USA, Inc. · 2006-03-17

Official Source

View FDA Recall →

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

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