Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, manufactured by Elekta Impac Software, Sunnyvale, CA
FDA device recall Z-0159-2011 · posted 2010-10-28 · Terminated
Recall details
- Recalling firm
- Impac Medical Systems Inc
- Reason for recall
- Mistreatment-- The database conversion utility used during the upgrade errantly changes the start gantry angle to zero. Any affected treatment fields, if not already treated, would start delivering from zero instead of the original prescribed value.
- Action taken
- ELEKTA IMPAC SOFTWARE sent a USER NOTICE dated February 19, 2010, to all customers. The notice identified the product, the problem, and the action to be taken by the customers. Customers were urged to verify the start angle of the gantry against the treatment field definition prior to delivery. Review all treatment plans and charts with conformal arcs. If a treatment plan with an errant gantry start angle was identified, customers were to cease using that plan immediately. A workaround was to be re-imported into their current version of MOSAIQ. IMPAC Support was to follow-up with each site and execute a script to detect and correct all affected treatment plans. For questions, concerns, and requests for upgrade, customers were to email support@impac.com or call their support center.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 19 units.
- Distribution
- Worldwide Distribution -- USA, Australia, Belgium, France, Germany, Hong Kong, Ireland, Israel, and Italy
- Date initiated
- 2010-02-19
- Date posted
- 2010-10-28
- Date terminated
- 2011-03-28
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SEQUENCER (K981313) | Impac Medical Systems, Inc. | 1998-07-09 |