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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 screenersee related information
Date Initiated by FirmJune 27, 2005
Date PostedJuly 13, 2005
Recall Status1 Terminated 3 on January 09, 2006
Recall NumberZ-0985-05
Recall Event ID 32518
510(K)NumberK013137 K030823 K852687 K936039 
Product Classification Tester, Auditory Impedance - Product Code ETY
ProductNatus 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
ActionThe 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 Commerce2473 units
DistributionProduct 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 CycleTPLC 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) Database510(K)s with Product Code = ETY
510(K)s with Product Code = ETY
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