Recall Z-2082-2019— Medical Intelligence Medizintechnik Gmbh

Name: FDA recall Z-2082-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-18

Class II · Terminated

Class II FDA medical device recall by Medical Intelligence Medizintechnik Gmbh, initiated 2019-07-18, terminated 2023-08-11. It names one FDA 510(k) clearance: K072079. Product: IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.. Reason: Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan..

Recalling firm: Medical Intelligence Medizintechnik Gmbh
Classification: Class II
Status: Terminated
Initiated: 2019-07-18
Terminated: 2023-08-11
Firm location: Schwabmunchen, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K072079 — IGUIDE SYSTEMMedical Intelligence Medizintechnik-GmbH-An Elekta·cleared 2007-08-14

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 System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

Reason for recall

Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan.

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