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Terminated

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.)

FDA Recall Z-0985-05 · Posted 2005-07-13

Recalling FirmNatus Medical Inc
Recall StatusTerminated
Product CodeETY
Date Initiated2005-06-27
Date Terminated2006-01-09
Product Quantity2473 units

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

Product was distributed worldwide, to distributors in Canada, Australia/New Zealand, Japan, the European Union, Bahamas, Bermuda, Chile, China, Hong Kong, INdia, Indonesia, Israel, Italy, Kuwait, Luxembourg, Malaysia, Nigeria, Quatar, Romania, Saudi Aabia, Singapore, Slovakia, South Africa, South Korea, Sweden, Switzerland, Taiwan and Thailand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030823ALGO 3I NEWBORN HEARING SCREENERNatus Medical, Inc. · 2003-04-09K013137ALGO 3 NEWBORN HEARING SCREENERNatus Medical, Inc. · 2001-10-16K936039ALGO-2 NEWBORN HEARING SCREENERNatus Medical, Inc. · 1995-01-05K852687ALGO IAlgotek, Inc. · 1985-09-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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