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U.S. Department of Health and Human Services

Class 2 Device Recall EyeSuite i.8.2.1.0 Software

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  Class 2 Device Recall EyeSuite i.8.2.1.0 Software see related information
Date Initiated by Firm January 05, 2017
Create Date March 20, 2017
Recall Status1 Terminated 3 on March 22, 2019
Recall Number Z-1500-2017
Recall Event ID 76405
510(K)Number K142423  
Product Classification System, image management, ophthalmic - Product Code NFJ
Product EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Code Information Model # 7220374 EyeSuite DICOM Option, 7220379 DICOM License .BQ 900 LED S/N: 3682  BQ LET Table S/N: 10038  BX 900 LED w/Digital EyeSuite S/N: 10016  CM 900 S/N: 354 & 491.  IM 900 / BQ 900 LED S/N: 919, 5036, 1136, 3146, 3147, 3148, 3150, 560, 3131, 2412 & 3011.  License Only S/N: 03011, 3210, BP5P922, 5617, 724, 1406, 3204, 2306, 2314, 2514, 3087, 1246, 2395 & 1063.  Lenstar S/N: 167, 285, 332, 416, 469, 656, 878, 1134, 1136, 1197, 1313, 1332, 1607, 2026, 2029, 2030, 2126, 2127, 2128, 2308, 2342, 2343, 2346, 2347, 2349, 2350, 2352, 2353, 2355, 2362, 2387, 2388, 2393, 2686, 2758, 2871, 2901, 2976, 3078, 3084, 3170, 3254, 20213, 3202, 579, 1298, 2055, 2118, 2737, 221, 485, 539, 639, 999, 1246, 2022, 2051, 2274, 2691, 2755, 2756, 2757, 2836, 2908, 3252, 3542, 3753, 3820, 3821, 3901, 3904, 3908, 3946, 3950, 20311, 20111, 20176, 20149 & 10.  Octopus 300 S/N: 4242, 3330, 3735 & 1506.  Octopus 600 S/N: 135, 246, 433, 434, 443, 708, 709, 710, 955, 956, 957, 958 & Demo.  Octopus 900 S/N: 2968, 1784, 2023, 2140, 2237, 2883, 2884, 2886, 2967, 3010, 3286, 3753, 1784, 1286, 1937, 2763, 2778, 3746, 3139, 2813, 1143, 1239, 1287, 2233, 2373, 2406, 2566, 2567, 2780, 2889, 2926, 3200, 2890, 2024, 1582, 1619, 1647, 2174, 2586, 2624, 3006, 3009, 3011 & 3372.
Recalling Firm/
Manufacturer		 Haag-Streit USA Inc
3535 Kings Mills Rd
Mason OH 45040-2303
For Additional Information Contact Mr. Russell F. Wolfe
513-398-3937 Ext. 1667
Manufacturer Reason
for Recall		 There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
FDA Determined
Cause 2		 Software design
Action On January 5, 2017 the firm sent Field Safety Notice to their customers.
Quantity in Commerce 163 units
Distribution US Nationwide distribution.
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 = NFJ and Original Applicant = HAAG-STREIT AG
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