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U.S. Department of Health and Human Services

Class 2 Device Recall ALGO Newborn Hearing screener

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  Class 2 Device Recall ALGO Newborn Hearing screener see related information
Date Initiated by Firm June 27, 2005
Date Posted July 13, 2005
Recall Status1 Terminated 3 on January 09, 2006
Recall Number Z-0985-05
Recall Event ID 32518
510(K)Number K013137  K030823  K936039  K852687  
Product Classification Tester, Auditory Impedance - Product Code ETY
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.)
Code Information 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.
Recalling Firm/
Manufacturer		 Natus Medical Inc
1501 Industrial Rd
San Carlos CA 94070
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ETY and Original Applicant = ALGOTEK, INC.
510(K)s with Product Code = ETY and Original Applicant = NATUS MEDICAL, INC.
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