Elekta, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0447-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.

Product Classification:

Class II

Date Initiated: November 24, 2015

Date Posted: December 23, 2015

Recall Number: Z-0447-2016

Event ID: 72725

Reason for Recall:

First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-allergy and duplicate drug therapy interaction checking.

Status: Terminated

Product Quantity: 211

Code Information:

Versions prior to 2.60.

Distribution Pattern:

Nationwide Distribution -- AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, & Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated