Recalls / —

—#77087

Product

Somatom Definition AS, Model number 8098027. Computed tomography x-ray system

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K081022

Affected lot / code info

Serial numbers: 64064, 64065, 64067, 64068, 64071, 64074, 64077, 64078, 64081, 64085, 64087, 64091, 64097, 64103, 64104, 64105, 64111, 64112, 64113, 64114, 64115, 64117, 64118, 64122, 64123, 64138, 64140, 64142, 64145, 64154, 64164, 64166, 64168, 64169, 64170, 64171, 64172, 64177, 64179, 64180, and 64181.

Why it was recalled

possible improper installation of tilt transport lock/tilt limiter

Root cause (FDA determination)

Labeling Change Control

Action the firm took

The recalling firm received a letter dated 11/25/08 from the manufacturer informing them of the problem. As a result, the recalling firm has issued Update Instruction CT065/08/S to have the transport lock/tilt limiter on the device visually inspected. The tilted scan modes have been disabled until the modified lock/tilt limiter has been installed.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

Nationwide Distribution --- including states of AZ, CA, CO, FL, IL, KS, KY, MA, MI, MN, MO, NE, NY, OH, PA, SC, VA, and WY.

Timeline

Recall initiated

2008-12-09

Posted by FDA

2009-01-23

Terminated

2009-09-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #77087. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.