FDA Device

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.)

Hazard

Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.

What You Should Do

Remedy

The firm plans to provide corrections via removal/replacement of the affected units directly to end users in the U.S. and work with distributors to perform removal and correction abroad.

Products

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 S
Brand
Natus Medical Inc
UPC
Product order numbers 010038, 010049, 010050, 010065, 010067, 010073, 010085, 030534, 040664, 040700, 040703, 040847, DM010038, DM010039, DM010049, DM010067, DM010074, LN030534. Serial numbers include P3 0547-P3 3404.

Units Affected

2473 units