Device recall

Z-0106-2012: "***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL…

FDA device recall · Class II · Invivo Corporation

Key facts

Recall number (Z-number) Z-0106-2012
Recall event 58984
Product "***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI Patient Monitoring System Model 865214***Use only with Model 989803169201 Power Adapter***REF 453564155341***SN US11401652***". Note: REF 453564155341, REF 453564181201, and 453564180091 are subject…
Product code MWI
Recalling firm Invivo Corporation
Recall class Class II
Status Terminated
Termination date Nov 15, 2012
510(k) numbers K090785
FEI number 1051786

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)