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U.S. Department of Health and Human Services

Class 1 Device Recall GENOSYL DS

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  Class 1 Device Recall GENOSYL DS see related information
Date Initiated by Firm May 19, 2021
Date Posted June 23, 2021
Recall Status1 Terminated 3 on October 12, 2023
Recall Number Z-1863-2021
Recall Event ID 87764
Product Classification Apparatus, nitric oxide delivery - Product Code MRN
Product GENOSYL DS; Nitric Oxide Delivery System

Combination Product NDA202860
Code Information Model #: 601588-01; Serial #'s: G0803, G0807, G0808, G0814, G0149, G0157, G0183, G0191, G0195, G0198, G0202, G0560, G0600, G0693, G0729, G0734, G0772, G0775, G0138, G0147, G0155, G0159, G0172, G0185, G0203, G0209, G0282, G0344, G0385, G0398, G0408, G0415, G0569, G0601, G0756, G0323, G0358, G0379, G0383, G0386, G0405, G0334, G0399, G0413, G0463, G0158, G0174, G0285, G0305, G0466, G0719, G0135, G0194, G0205, G0281, G0362, G0407, G0573, G0574, G0578, G0579, G0582, G0583, G0587, G0590, G0591, G0594, G0596, G0597, G0598, G0603, G0609, G0611, G0680, G0708, G0110, G0111, G0131, G0137, G0140, G0176, G0207, G0212, G0232, G0237, G0246, G0251, G0253, G0262, G0263, G0266, G0280, G0449, G0453, G0608, G0642, G0644, G0663, G0688, G0712, G0717, G0739, G0745, G0747, G0762, G0764, G0765, G0793, G0125, G0129, G0133, G0169, G0181, G0257, G0292, G0645, G0804, G0180, G0293, G0311, G0322, G0338, G0341, G0342, G0353, G0480, G0499, G0506, G0519, G0521, G0522, G0565, G0681, G0735, G0738, G0748, G0754, G0760, G0770, G0773, G0773, G0782, G0223, G0227, G0235, G0236, G0347, G0352, G0355, G0359, G0378, G0382, G0175, G0273, G0476, G0562, G0792, G0162, G0163, G0189, G0607, G0143, G0160, G0164, G0214, G0215, G0283, G0284, G0296, G0298, G0303, G0313, G0315, G0319, G0329, G0333, G0335, G0370, G0375, G0495, G0509, G0510, G0511, G0550, G0571, G0588, G0589, G0593, G0646, G0672, G0689, G0723, G0724, G0725, G0736, G0744, G0771, G0778, G0795, G0204, G0218, G0269, G0272, G0343, G0580, G0193, G0294, G0300, G0302, G0308, G0465, G0518, G0567, G0190, G0278, G0279, g0286, G0297, G0374, G0393, G0728, G0307, G0309, G0312, G0318, G0320, G0406, G0434, G0643, G0229, G0230, G0231, G0240, G0460, G0469, G0488, G0489, G0493, G0496, G0500, G0501, G0599, G0605, G0610, G0647, G0648, G0650, G0651, G0653, G0654, G0655, G0656, G0658, G0661, G0667, G0668, G0670, G0671, G0677, G0678, G0686, G0691, G0694, G0697, G0702, G0707, G0713, G0715, G0716, G0718, G0726, G0730, G0733, G0741, G0755, G0806, G0813, G0818, G0261, G0270, G0274, G0275, G0094, G0363, G0369, G0430, G0435, G0440, G0444, G0452, G0475, G0487, G0490, G0508, G0537, G0549, G0234, G0380, G0389, G0402, G0409, G0483, G0497, G0576, G0584, G0585, G0277, G0346, G0390, G0423, G0443, G0445, G0447, G0451, G0454, G0455, G0457, G0458, G0459, G0461, G0464, G0467, G0474, G0479, G0481, G0486, G0492, G0504, G0512, G0515, G0516, G0517, G0520, G0524, G0527, G0528, G0529, G0531, G0532, G0533, G0536, G0539, G0542, G0545, G0546, G0547, G0551, G0552, G0553, G0554, G0557, G0558, G0559, G0561, G0570, G0581, G0602, G0710, G0743, G0749, G0752, G0768, G0787, G0289, G0371, G0357, G0372, G0391, G0701, G0186, G0327, G0337, G0568, G0604, G0675, G0679, G0682, G0692, G0700, G0703, G0396, G0397, G0228, G0245, G0288, G0387, G0414, G0418, G0420, G0437, G0439, G0535, G0572, G0211, G0268, G0365, G0544, G0592, G0252, G0349, G0606, G0192, G0417, G0485, G0507, G0523, G0563, G0146, G0166, G0304, G0306, G0314, G0332, G0339, G0403, G0422, G0424, G0428, G0429, G0431, G0432, G0436, G0450, G0473, G0491, G0426, G0427, G0301, G0425, G0706, G0720, G0722, G0727, G0789, G0797, G0799, G0805, G0665, G0684, G0696, G0714, G0740, G0796, G0367, G0595, G0721, G0731, G0732, G0109, G0124, G0136, G0139, G0331, G0468, G0566, G0810, G0816, G0381, G0767, G0779, G0790, G0737, G0763, G0766, G0774 
Recalling Firm/
Manufacturer		 Vero Biotech, LLC
387 Technology Cir Nw Ste 125
Atlanta GA 30313-2411
For Additional Information Contact
877-337-4418
Manufacturer Reason
for Recall		 Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.
FDA Determined
Cause 2		 Software design
Action The firm initiated their recall by visit on 04/07/2021. VERO Clinical Educators are going (or have gone) onsite to the hospitals to physically upgrade the software to v2.2.4. The correction of upgrading the software from v2.2.3 to v2.2.4 began on Wednesday April 7, 2021. The software upgrade is expected to be completed by Friday April 23, 2021. For questions contact VERO Biotech at 1-877-337-4118 or visit the VERO Biotech website at https://www.vero-biotech.com/.
Quantity in Commerce 465 units
Distribution Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC
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.
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