Device recall

Z-2066-2011: OB-Link release 2.0.7. distributed by Digisonics, Inc., 3701 Kirby Drive…

FDA device recall · Class II · Digisonics, Inc

Key facts

Recall number (Z-number) Z-2066-2011
Recall event 58371
Product OB-Link release 2.0.7. distributed by Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098 OBLink provides automated transmission of patient data and measurements from ultrasound systems directly to Digisonics OB-View/OB-Windows systems.
Product code HEM
Recalling firm Digisonics, Inc
Recall class Class II
Status Terminated
Termination date May 2, 2011
FEI number 1626313

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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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