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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 14, 2005
Date Posted November 24, 2005
Recall Status1 Terminated 3 on April 14, 2015
Recall Number Z-0196-06
Recall Event ID 33939
510(K)Number K040995  
Product Classification System, X-Ray, Stationary - Product Code KPR
Product Analogic SyneRad Multi Digital Radiology System, Model AN6150
Code Information Serial Numbers: 3604-M0120;5004-M0125;3204-M0118; 5004-M0126;4404-M0124;3204-M0119;3005-M0131;2404-M0115;2404-M0117;0205-M0130;3604-M0121;3904-M0122;5004-M0127;3805-M0132;2705-M0128;3904-M0123;0205-M0129
Recalling Firm/
Manufacturer		 Analogic Corporation
Centennial Industrial park
8 Centennial Drive
Peabody MA 01960-7902
For Additional Information Contact Donald Sherratt
978-326-4075
Manufacturer Reason
for Recall		 Potential weld defect in the Overhead Tube Support assembly which connects to the telescoping arm. This could cause the tube assembly to fall, leading to possiible injury of the user or patient.
FDA Determined
Cause 2		 Other
Action Analogic Corp notified accounts by email on 10/14/2005 and by letter on 10/17/2005. Accounts are requested to stop use and correction will be conducted by a service engineer.
Quantity in Commerce 17 UNITS
Distribution AZ, CA, FL, MA, OH, PA, TN, TX,
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 = KPR and Original Applicant = ANALOGIC CORP.
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