Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: G110307, H110482, H110484, H110487, H110489, G110334, G110338, G110404, G110296, G110358, G110340, G110341, G110407, G110409, H110432, G110345, H110450, G110391, H110476, H110443, H110446, G110400, H110483, G110394, G110406, H110411, H110497, G110360, G110363, G110364, G110371, G110366, G110368, G110372, H110434, H110447, G110380, H110455, G110298, H110445, H110449, H110461, G110292, G110346, G110365, H110494, H110495, H110474, G110376, G110319, G110328, H110473, H110413, H110414, H110427, H110453, H110454, H110415, G110312, G110321, H110467, H110471, H110412, G110289, G110303, G110294, H110420, G110299, G110300, H110448, H110452, G110386, G110331, H110451, H110493, G110313, G110314, H110464, H110496, H110433, G110373, G110375, G110317, H110431, H110417, G110291, G110302, G110369, G110378, G110335, G110387, G110390, G110392, G110395, G110311, G110327, G110332, G110382, G110355, G110357, G110287, G110320, H110435, H110481, H110485, H110486, G110354, G110316, G110318, G110362, G110393, H110498, H110456, H110457, H110459, G110337, G110356, H110421, H110429, G110290, G110352, H110470, H110478, G110383, G110384, G110361.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Pentax of America Inc
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
Product Codes/Lot Numbers:
Serial Numbers: G110307, H110482, H110484, H110487, H110489, G110334, G110338, G110404, G110296, G110358, G110340, G110341, G110407, G110409, H110432, G110345, H110450, G110391, H110476, H110443, H110446, G110400, H110483, G110394, G110406, H110411, H110497, G110360, G110363, G110364, G110371, G110366, G110368, G110372, H110434, H110447, G110380, H110455, G110298, H110445, H110449, H110461, G110292, G110346, G110365, H110494, H110495, H110474, G110376, G110319, G110328, H110473, H110413, H110414, H110427, H110453, H110454, H110415, G110312, G110321, H110467, H110471, H110412, G110289, G110303, G110294, H110420, G110299, G110300, H110448, H110452, G110386, G110331, H110451, H110493, G110313, G110314, H110464, H110496, H110433, G110373, G110375, G110317, H110431, H110417, G110291, G110302, G110369, G110378, G110335, G110387, G110390, G110392, G110395, G110311, G110327, G110332, G110382, G110355, G110357, G110287, G110320, H110435, H110481, H110485, H110486, G110354, G110316, G110318, G110362, G110393, H110498, H110456, H110457, H110459, G110337, G110356, H110421, H110429, G110290, G110352, H110470, H110478, G110383, G110384, G110361.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3067-2017
Related Recalls
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Pentax of America
During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane.
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.