Device recall

Z-1992-2016: Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1)…

FDA device recall · Class II · Med Tec Inc

Key facts

Recall number (Z-number) Z-1992-2016
Recall event 73692
Product Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041
Product code JAI
Recalling firm Med Tec Inc
Recall class Class II
Status Terminated
Termination date Feb 3, 2017
510(k) numbers K132084
FEI number 1000143606

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)