Recalls / —

—#85552

Product

Siemens Biograph mCT-S 64, model number 10248672. Medical Imaging Equipment.

FDA product code

KPS — System, Tomography, Computed, Emission

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K060631

Affected lot / code info

serial numbers: 1002 and 1003

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA Inc.

Address

810 Innovation Dr, Knoxville, Tennessee 37932-2562

Distribution

Distribution pattern

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

Timeline

Recall initiated

2009-08-11

Posted by FDA

2009-11-10

Terminated

2009-12-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #85552. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.