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.
Recall
- Recall Number
- Z-1029-2011
- Event Number
- 55087
- Firm
- Impac Medical Systems Inc
- FEI Number
- 1000123805
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- March 10, 2010
- Posted
- February 4, 2011
- Terminated
- April 6, 2011
- Address
- 100 Mathilda Pl, Fl 5th, Sunnyvale, CA, 94086-6076
Description
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.
Computer interface is defected. Computer based verification system for recording patient treatment on a radiotherapy treatment machine fails to record treated field.
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 [email protected] 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.
Worldwide Distribution -- US, Canada, Germany, and France.
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