Focal SIM Planning of radiation therapy
FDA device recall Z-2002-2012 · posted 2012-07-12 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
- Action taken
- IMPAC Medical Systems, Inc. sent an Important Safety Notice LINFFM0001/1.0 on June 21, 2012, to consignees on concerning a patch to the software. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the DICOM coordinates option for Reports when printing the Setup Reference Diaglog. Customers were instructed go to www.elekta.com, select the SupportPlus Login at the tope of the page, enter their portal, select Downloads/Updates to download the latest patches. For questions regarding this recall call 770-670-2548.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 38 units
- Distribution
- Nationwide Distribution including CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI.
- Date initiated
- 2012-06-21
- Date posted
- 2012-07-12
- Date terminated
- 2014-04-01
- Location
- Norcross, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FOCAL SIM (K013112) | Computerized Medical Systems, Inc. | 2001-12-05 |