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U.S. Department of Health and Human Services

Class 2 Device Recall BuckyDiagnost with Optimus Generator

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 Class 2 Recall
BuckyDiagnost with Optimus Generator
see related information
Date Posted March 04, 2011
Recall Status1 Open
Recall Number Z-0905-2011
Recall Event ID 58077
Premarket Notification
510(K) Number
K945527 
Product Classification Generator, High-Voltage, X-Ray, Diagnostic - Product Code IZO
Product BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose Diagnostic Radiography.
Code Information 704031 / 70408
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Affected systems were determined not to prevent run-on of a selected technique factor if the technique selector and the exposure control were activated simultaneously.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action A Customer Information BuckyDiagnost Diagnostic X-Ray System letter, dated January 6, 2011, was sent to customers. The letter identifies the affected product, the reason for the recall, actions that are to be taken by customers, and actions that are planned by the firm. Customers are advised to make sure that the desired exposure values are displayed and that they have released the technique button BEFORE they start the exposure by pressing the exposure switch whenever manually changing the exposure parameters and in order to avoid the problem. Philips will issue a Field Change Order (FCO) to resolve the issue by updating the system software free of charge. Philips will contact customers to implement the FCO. Further information or support concerning this issue can be obtained by contacting your local Philips representative. The Field Service Engineers began software implementation the week of March 21, 2011.
Quantity in Commerce 1810 units in the US
Distribution Worldwide Distribution
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 = IZO and Original Applicant = KARL STORZ ENDOSCOPY-AMERICA, INC.
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