Device recall

Z-0115-06: BirthNet OB Data Management System 91861

FDA device recall · Class III · Spacelabs Medical Incorporated

Key facts

Recall number (Z-number) Z-0115-06
Recall event 33769
Product BirthNet OB Data Management System 91861
Product code HGM
Recalling firm Spacelabs Medical Incorporated
Recall class Class III
Status Terminated
Termination date Jan 17, 2011
510(k) numbers K965008
FEI number 3010157426

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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