Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recallsee related information
Date Initiated by FirmOctober 14, 2005
Date PostedNovember 24, 2005
Recall Status1 Terminated 3 on April 14, 2015
Recall NumberZ-0196-06
Recall Event ID 33939
510(K)NumberK040995 
Product Classification System, X-Ray, Stationary - Product Code KPR
ProductAnalogic 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
FEI Number 1220672
Recalling Firm/
Manufacturer		 Analogic Corporation
Centennial Industrial park
8 Centennial Drive
Peabody MA 01960-7902
For Additional Information ContactDonald 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
ActionAnalogic 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 Commerce17 UNITS
DistributionAZ, CA, FL, MA, OH, PA, TN, TX,
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KPR
-
-