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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm September 15, 2004
Date Posted November 06, 2004
Recall Status1 Terminated 3 on February 15, 2005
Recall Number Z-0186-05
Recall Event ID 29999
510(K)Number K880773  
Product Classification Stimulator, Photic, Evoked Response - Product Code GWE
Product The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device, Manufactured by Diopsys, Inc., 355 Main St., Metuchen, NJ 08840. Each medical device unit is assembled and contains an 18 inch flat panel vision stimulator panel, a 17 inch flat panel operator monitor, a 2.25 inch thermal printer, a mobile point of care cart, medical grade battery back-up, speaker, a CPU with floppy and CD drives, a camera and an isolation transformer.
Code Information No manufacturing codes are affixed to the units. The firm maintains some in-house identification numbers which are: 10001; 10003; 10004; 10005; 10006; 10007; 10008; 10009; 100010; 100011; 100012; 100013; 100014; 100015; 100016.
Recalling Firm/
Manufacturer		 Diopsys Inc
355 Main St
Metuchen NJ 08840
For Additional Information Contact Joseph A. Fontanetta
732-321-6566 Ext. 11
Manufacturer Reason
for Recall		 The firm established no medical device quality system, no established quality plan and no established quality procedures.
FDA Determined
Cause 2		 Other
Action The firm sent out a recall letter to their customers on 09/14/2004 stating that a field correction will be conducted at each site.
Quantity in Commerce 18 units
Distribution The firm distributes the Enfant VEP medical device systems in 3 states, NY, NJ, and CT at the current time. There is no international distribution at this time. There are no Government, or military accounts. The rental/leasing of the units are direct. No contracts have been established. There are 17 domestic consignees.
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 = GWE and Original Applicant = NEUROSCIENTIFIC CORP.
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