Ultrasound Video Gastroscope recall
Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi…
Why was Ultrasound Video Gastroscope recalled?
Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
H110516, H110619, H110635, H110643, H110624, A110407, A110411, H110507, A110352, A110444, A110417, A110419, H110493, H110494, H110522, H110584, H110586, H110590, H110591, H110559, A110471, A110474, A110355, A110359, H110606, H110566, H110568, H110498, H110503, H110509, H110510, H110637, H110560, H110514, A110427, A110372, A110438, H110587, H110598, H110600, A110439, A110440, A110443, A110450, A110448, A110451, A110453, H110542, H110569, A110445, A110454, H110565, A110356, A110357, H110592, H110593, H110595, A110346, H110508, A110461, H110620, H110623, H110641, H110642, H110613, A110460, A110380, A110463, H110577, A110457, A110401, H110610, H110611, H110502, H110511, H110518, H110519, H110578, H110557, H110561, A110422, A110432, H110512, H110626, H110628, H110629, H110633, H110634, H110539, H110544, A110341, A110418, H110596, H110604, A110387, A110388, H110601, H110615, H110571, H110574, H110599, H110506, A110350, A110398, H110575, A110449, A110360, A110363, A110368, H110554, H110515, H110567, A110410, A110414, A110485, H110553, H110563, H110589, A110376, A110384, H110549, H110564, H110556, H110536, H110646, H110533, H110543, A110458, A110459, A110383, H110538, H110499, A110344, A110345, A110348, A110452, A110391, A110475, A110483, A110486, A110488, A110477, A110479, A110480, A110481, A110482, A110375, A110406, A110470, A110429, A110435, H110618, A110393, A110394, A110447, A110462, A110466, H110555, H110631, H110636, H110639, H110524, H110525, H110526, H110530, H110531, H110532, H110534, H110535, A110476, A110416, A110420, A110379, A110381, A110385, A110484, A110492, H110640, H110579, H110581, H110572, H110573, A110425, A110431, A110441, A110442, H110517, A110426, A110433, A110434, A110353, H110614, H110616, A110464, A110465, H110520, H110523, H110550.
- Product
- Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi…
- Recalling firm
- Pentax of America Inc
- Quantity
- US: 116 units
- Distribution
- Nationwide
- Recall date
- August 30, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)