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U.S. Department of Health and Human Services

Class 2 Device Recall SEQUENCER for Mosaiq

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  Class 2 Device Recall SEQUENCER for Mosaiq see related information
Date Initiated by Firm March 10, 2010
Date Posted February 04, 2011
Recall Status1 Terminated 3 on April 06, 2011
Recall Number Z-1029-2011
Recall Event ID 55087
510(K)Number K981313  
Product Classification Medical Linear Accelerator - Product Code IYE
Product SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines.

Sequencer Verify and Record System is to assist in the process of patient treatment on a radiotherapy treatment machine with software control.
Code Information Sequencer for MOSAIQ versions: 1.20, 1.30 ; 1.50 , 1.60 and 2.00, interfacing to an Elekta SL 75-5 Linacs.
Recalling Firm/
Manufacturer		 Impac Medical Systems Inc
100 Mathilda Pl Fl 5th
Sunnyvale CA 94086-6076
For Additional Information Contact
408-830-8007
Manufacturer Reason
for Recall		 Computer interface is defected. Computer based verification system for recording patient treatment on a radiotherapy treatment machine fails to record treated field.
FDA Determined
Cause 2		 Software design
Action A User Notice was sent by the firm to its consignees. It identified the affected product and the reason for the recall. It also discussed the clinical impact and interim mitigations. The firm states in the letter that a fix for the problem and been developed and is available. Customers are to contact IMPAC Support for the patch to the SL75-5 interface. If customers have questions, concerns, or requests, they can email support@impac.com or one of the numbers listed in the letter for the applicable country. The letter should be distributed to all users affected by the issue at the customer's organization.
Quantity in Commerce 40
Distribution Worldwide Distribution -- US, Canada, Germany, and France.
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 = IYE and Original Applicant = IMPAC MEDICAL SYSTEMS, INC.
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