FDA Medical Device Recalls (openFDA)
Natus Medical Inc: 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.)
- Recall number
- Z-0985-05
- Recalling firm
- Natus Medical Inc
- 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.)
- Status
- Terminated
- Initiated
- 2005-06-27
- Posted
- 2005-07-13
- Terminated
- 2006-01-09
- Reason
- Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- K013137, K030823, K852687, K936039
- PMA numbers
- not on file
- Product code
- ETY
- Firm FEI
- 2938854
- Firm city
- San Carlos
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28