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U.S. Department of Health and Human Services

Class 3 Device Recall Arcadis Orbic

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  Class 3 Device Recall Arcadis Orbic see related information
Date Initiated by Firm August 01, 2005
Date Posted November 02, 2005
Recall Status1 Terminated 3 on July 19, 2006
Recall Number Z-0119-06
Recall Event ID 33082
510(K)Number K040066  
Product Classification System, X-Ray, Mobile - Product Code IZL
Product Arcadis Orbic Mobile X-Ray System
Code Information Model number 8081080
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter
610-448-1777
Manufacturer Reason
for Recall		 Screws may become loose and fall into the OR field during surgery.
FDA Determined
Cause 2		 Other
Action The recalling firm has their Service Engineers visiting each site to check the screws on the window and secure them with Loctite per Update Instructions SP022/05/S. The Service Engineer is also informing the account of the problem during the visits.
Quantity in Commerce 21 units
Distribution The products were shipped nationwide to a distributor, a physician, and medical facilities
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 = IZL and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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