Device recall

Z-2270-2014: Philips IP5 Information Portal The Expression Information Portal (Model IP5), a…

FDA device recall · Class II · Invivo Corporation

Key facts

Recall number (Z-number) Z-2270-2014
Recall event 68956
Product Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.
Product code MWI
Recalling firm Invivo Corporation
Recall class Class II
Status Terminated
Termination date Dec 14, 2016
510(k) numbers K121424
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)