Device recall

Z-1084-05: Optimus 30

FDA device recall · Class II · Philips Ultrasound, Inc.

Key facts

Recall number (Z-number) Z-1084-05
Recall event 33411
Product Optimus 30
Product code KPR
Recalling firm Philips Ultrasound, Inc.
Recall class Class II
Status Terminated
Termination date Sep 27, 2010
510(k) numbers K945278
FEI number 3019216

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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