Device recall

Z-2150-2012: Finapres Medical Systems Portapres with NiMh battery pack Product Usage…

FDA device recall · Class II · FMS, Finapres Medical Systems BV

Key facts

Recall number (Z-number) Z-2150-2012
Recall event 62556
Product Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.
Product code DXN
Recalling firm FMS, Finapres Medical Systems BV
Recall class Class II
Status Terminated
Termination date Sep 12, 2012
510(k) numbers K023338
FEI number 3003803088

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

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