Recall Z-3017-2017— Elekta, Inc.

Name: FDA recall Z-3017-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-19

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2017-06-19, terminated 2019-11-05. It names one FDA 510(k) clearance: K143485. Product: iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.. Reason: Incorrect PEC values..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-19
Terminated: 2019-11-05
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K143485 — iGuide 2.1Medical Intelligence Medizintechnik GmbH·cleared 2015-03-04

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

iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

Reason for recall

Incorrect PEC values.

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