Device recall

Z-0987-2007: HD11XE Diagnostic Ultrasound System

FDA device recall · Class II · Philips Medical Systems

Key facts

Recall number (Z-number) Z-0987-2007
Recall event 37888
Product HD11XE Diagnostic Ultrasound System
Product code IYN
Recalling firm Philips Medical Systems
Recall class Class II
Status Terminated
Termination date Jan 24, 2011
510(k) numbers K043535
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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