Device recall

Z-1929-2011: GE The CARESCAPE Monitor B850 includes both new and existing subsystems…

FDA device recall · Class II · GE Healthcare, LLC

Key facts

Recall number (Z-number) Z-1929-2011
Recall event 57288
Product GE The CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a high acuity, multi-parameter patient monitoring system. A typical configuration would be a CARESCAPE Monitor B850 host processing unit running the CARESCAPE Monitoring platform software, a display with…
Product code MHX
Recalling firm GE Healthcare, LLC
Recall class Class II
Status Terminated
Termination date Jun 5, 2012
510(k) numbers K092027
FEI number 2126677

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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

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