SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. Sequencer Verify and Record System is to assist in the proces
FDA device recall Z-1029-2011 · posted 2011-02-04 · Terminated
Recall details
- Recalling firm
- Impac Medical Systems Inc
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 40
- Distribution
- Worldwide Distribution -- US, Canada, Germany, and France.
- Date initiated
- 2010-03-10
- Date posted
- 2011-02-04
- Date terminated
- 2011-04-06
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SEQUENCER (K981313) | Impac Medical Systems, Inc. | 1998-07-09 |