Recall Z-0985-05 ยท ETY Tester, Auditory Impedance
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.)
| Date | Jul 13, 2005 (initiated Jun 27, 2005) |
| Status | Terminated |
| 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 Ko |
| FDA record | Open on fda.gov |