FDA-Device2012-07-18Class II

Focal SIM Planning of radiation therapy

Elekta, Inc.
Hazard

Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.

Sold states
Nationwide Distribution including CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI.
Affected count
38 units
Manufactured in
4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross, GA, United States
Products
Focal SIM Planning of radiation therapy

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2002-2012

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief