Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Reason for recall: Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads. Distribution: US Nationwide distribution. Quantity: 28 Lot/code info: Model Number: PCF-HQ190L; UDI DI: 4953170416118; Serial Number: 2000569, 2001007, 2101185, 2101301, 2101313, 2101860, 2102339, 2102634, 2102740, 2103215, 2103257, 2103483, 2103614, 2103674, 2203899, 2203915, 2204096, 2204400, 2204659, 2204820, 2205238, 2205684, 2206065, 2206501, 2307200, 2307709, 2307713, 2308226;
4953170416118
Official record: FDA (Device enforcement) ↗
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