FDA recall Z-2082-2019

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 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.

Distribution

Worldwide Distribution - US Nationwide

Key facts

Status

Terminated

Initiation date

2019-07-18

Report date

2019-07-31

Termination date

2023-08-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Schwabmunchen, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2082-2019