FDAFDA · Food and drugs·Recall number Z-0821-2015
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
Published December 24, 2014 · Recall initiated: December 2, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with Image Angle Information Used for the 1st Port Image, for a subsequent port image fusion. As the result, ExacTrac may display a Digitally Reconstructed Radiograph (DRR) image taken from the angle for the 1st port image fusion, rather than the one taken from the angle for the intended port
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
- Distributor
- US Distribution to the states of NY, FL, TX and OH.
- Lot
- Serial Numbers: 201902, 203901, 203919, and 203924 (US only)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
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