Recall Z-2591-2021— Elekta, Inc.

Name: FDA recall Z-2591-2021
Creator: U.S. Food and Drug Administration
Published: 2021-09-02

Class II · Ongoing

Class II FDA medical device recall by Elekta, Inc., initiated 2021-09-02. It names one FDA 510(k) clearance: K183034. Product: MOSAIQ Oncology Information System. Reason: A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-09-02
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K183034 — MOSAIQ Oncology Information SystemElekta, Inc.·cleared 2018-12-04

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

A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.

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