SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO, Manufactured by I
FDA device recall Z-1515-2008 · posted 2008-08-16 · Terminated
Recall details
- Recalling firm
- Impac Medical Systems Inc
- Reason for recall
- Software issue may result in change to intended treatment field, potentially resulting in mistreatment.
- Action taken
- Firm issued field advisory to its consignees on 02/14/2008. Phone calls will also be made to affected customers to ensure reception and understanding of the field notification. Firm advises users with affected product to review the jaw positions of IMRT fields to ensure that they match the RT Plan after an Apply Limits or Machine Change occurs, until software at their site can be updated to the corrected version. A software patch is under construction.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 36 units
- Distribution
- Worldwide Distribution --- USA including states of OH, OK, NJ, MN, OR, TN, NY, CA, AZ, NV, IA, GA, AL, MD, MI, PA, IN, WA, FL, TX, CO, and countries to Canada, Australia, Germany, Greece and Sweden.
- Date initiated
- 2008-02-14
- Date posted
- 2008-08-16
- Date terminated
- 2009-06-24
- 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 |