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U.S. Department of Health and Human Services

Class 2 Device Recall Somatom Definition AS

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 Class 2 Recall
Somatom Definition AS
see related information
Date Posted January 23, 2009
Recall Status1 Terminated on September 23, 2009
Recall Number Z-0929-2009
Recall Event ID 50770
Premarket Notification
510(K) Number
K081022 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Somatom Definition AS, Model number 8098027. Computed tomography x-ray system
Code Information 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.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Michael Van Ryn
610-448-4500
Manufacturer Reason
for Recall
possible improper installation of tilt transport lock/tilt limiter
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control
Action 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.
Quantity in Commerce 42 units
Distribution Nationwide Distribution --- including states of AZ, CA, CO, FL, IL, KS, KY, MA, MI, MN, MO, NE, NY, OH, PA, SC, VA, and WY.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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