Recall Z-0447-2016— Elekta, Inc.

Name: FDA recall Z-0447-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-24

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2015-11-24, terminated 2021-09-15. It names one FDA 510(k) clearance: K141572. Product: MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.. Reason: 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..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-11-24
Terminated: 2021-09-15
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K141572 — MOSAIQ ONCOLOGY INFORMATION SYSTEMImpac Medical Systems, Inc.·cleared 2014-09-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.