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U.S. Department of Health and Human Services

Class 2 Device Recall Somatom Definition

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 Class 2 Recall
Somatom Definition
see related information
Date Posted July 30, 2009
Recall Status1 Terminated on September 01, 2009
Recall Number Z-1675-2009
Recall Event ID 52435
Premarket Notification
510(K) Number
K081022 
Product Classification System, X-Ray, Tomography, Computed - 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, Pennsylvania 19355
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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 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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