EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
Check against the official notice below — it lists the full affected range.
Olympus Corporation of the Americas is recalling eight EVIS EXERA II Gastrointestinal Videoscopes (Model GIF-HQ190) distributed across Alabama, Florida, North Carolina, and New York. During repair at Olympus, an incorrect A-rubber part intended for a different videoscope model may have been installed on these units. The incorrect part fits too tightly on the GIF-HQ190 and does not meet the device's intended design specifications.
The affected units have the following serial numbers: 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773, and 2962545. The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications
Reason for recall: Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications Distribution: US Nationwide distribution in the states of AL, FL, NC, NY. Quantity: 8 units Lot/code info: UDI-DI: 04953170305276 Serial: 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773 and 2962545
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.