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U.S. Department of Health and Human Services

Class 2 Device Recall Somatom Definition

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  Class 2 Device Recall Somatom Definition see related information
Date Initiated by Firm May 29, 2009
Date Posted July 30, 2009
Recall Status1 Terminated 3 on September 01, 2009
Recall Number Z-1675-2009
Recall Event ID 52435
510(K)Number K081022  
Product Classification Computed Tomography X-Ray System - Product Code JAK
Product Somatom Definition Model AS/AS+, Model number 8098027.

Intended use: Computed Tomography X-ray system
Code Information Serial numbers: 63241, 64009, 64014, 64064, 64065, 64067, 64068, 64071, 64074, 64077, 64078, 64079, 64081, 64082, 64085, 64087, 64091, 64097, 64103, 64104, 64105, 64112, 64113, 64114, 64115, 64117, 64118, 64122, 64123, 64138, 64140, 64142, 64145, 64154, 64164, 64168, 64169, 64170, 64171, 64172, 64177, 64178, 64179, 64180, 64181, 64189, 64190, 64194, 64199, 64202, 64212, 64214, 64228, 64231, 64232, 64235, 64236, 64239, 64243, 64244, 64245, 64246, 64248, 64253, 64258, 64259, 64260, 64261, 64263, 64270, 64271, 64272, 64273, 64274, 64278, 64282, 64284, 64289, 64290, 64291, 64293, 64296, 64297, 64308, 64310, 64314, 64328, 64337, 64340, 64342, 64347, 64352, and 64354.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact michael Van Ryn
610-448-4634
Manufacturer Reason
for Recall		 Support mechanism may not engage properly due to improper stowage after opening which may result in internal component damage or potential injury.
FDA Determined
Cause 2		 Equipment maintenance
Action The firm has issued a modification of the telescope support arm parking bracket via Update Instruction CT028/09/S. A firm service representative will install the modified support arm parking brackets on the affected systems.
Quantity in Commerce 93 units
Distribution Nationwide Distribution -- including states of AR, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, MA, MD, MN, MO, MT, NC, ND, NE, NH, NY, OH, PA, SC, SD, TN, VA, WA, WI, and WY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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