Z-0985-05

Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i...

Name: Z-0985-05 Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i...
Creator: Natus Medical Inc
Published: 2005-06-27
License: https://open.fda.gov/license/

Bio-Logic Systems Corp. / initiated 2005-06-27 / Terminated

FDA source

Natus Medical Inc began a recall of 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... on 2005-06-27. The reason FDA records is "Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0985-05
Status: Terminated
Initiated: 2005-06-27
Posted: 2005-07-13
Terminated: 2006-01-09
Recalling firm: Bio-Logic Systems Corp.
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 Tester, Auditory Impedance
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.
FDA root cause: Other
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.
Quantity in commerce: 2473 units
Distribution: 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.
Product codes and lots: 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.

Product code ETY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)