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 |
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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.
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510(K) Database | 510(K)s with Product Code = IYE
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