Recall Z-2293-2016— Elekta, Inc.

Name: FDA recall Z-2293-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-15

Class II · Ongoing

Class II FDA medical device recall by Elekta, Inc., initiated 2016-07-15. It names one FDA 510(k) clearance: K123230. Product: MOSAIQ Oncology Information System. Reason: It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2016-07-15
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K123230 — MOSAIQ ONCOLOGY INFORMATION SYSTEMImpac Medical Systems, Inc.·cleared 2012-12-12

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

Reason for recall

It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.

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