Device recall

Z-0985-05: Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn…

FDA device recall · Class II · Natus Medical Inc

Key facts

Recall number (Z-number) Z-0985-05
Recall event 32518
Product Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing Screener.)
Product code ETY
Recalling firm Natus Medical Inc
Recall class Class II
Status Terminated
Termination date Jan 9, 2006
510(k) numbers K013137, K030823, K936039
FEI number 2938854

At a glance

  • 1–9 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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