Device recall

Z-0998-2026: The AlignRT InBore system contains six Class 1 lasers which enables the system s…

FDA device recall · Class II · Vision RT Ltd

Key facts

Recall number (Z-number) Z-0998-2026
Recall event 98236
Product The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Product code IWE
Recalling firm Vision RT Ltd
Recall class Class II
Status Open, Classified
FEI number 3004832819

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)