FDA (Devices) recall action 73088
The FDA (Devices) publishes a recall like this one as 22 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 22 pages.
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Integrated Medical Systems Inc is recalling 122 Olympus video colonoscopes because excessive pressure may cause the internal coil pipe assembly to detach, affecting angulation.
Integrated Medical Systems Inc is recalling three Olympus PCF-140L video colonoscopes because the internal coil pipe assembly may detach under excessive pressure.
Integrated Medical Systems Inc is recalling 12 Olympus GIF-140 video gastroscopes because the internal coil pipe assembly may detach under pressure, causing angulation failure.
Integrated Medical Systems Inc is recalling four Olympus GIF-XQ140 video gastroscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing proper angulation.
Integrated Medical Systems Inc is recalling 21 Olympus GIF-XP160 video gastroscopes because excessive pressure may cause the internal coil pipe assembly to detach, preventing proper angulation.
Integrated Medical Systems is recalling 190 Olympus PCF-H180AL pediatric colonoscopes because excessive pressure can cause the internal coil pipe to detach, preventing proper angulation.
Integrated Medical Systems Inc. is recalling 232 Olympus CF-H180AL video colonoscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing angulation from operating as intended.
Integrated Medical Systems Inc is recalling 16 Olympus TJF-160F video duodenoscopes because excessive pressure can cause the internal coil pipe to detach, preventing proper angulation.
Integrated Medical Systems Inc is recalling 180 Olympus GIF-H180J video gastroscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing proper angulation.
Integrated Medical Systems Inc is recalling 26 Olympus CF-Q160L video colonoscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing angulation from operating as intended.
Integrated Medical Systems is recalling five Olympus video colonoscopes because the internal coil pipe assembly may detach if excessive pressure is applied to the distal end.
Integrated Medical Systems Inc. is recalling 54 Olympus GIF-Q160 video gastroscopes because excessive pressure may cause the internal coil pipe assembly to detach, preventing proper angulation.
Integrated Medical Systems Inc is recalling two Olympus CF-Q140L video colonoscopes because excessive pressure can cause the internal coil pipe assembly to detach.
Integrated Medical Systems Inc. is recalling one Olympus PCF-H190L video pediatric colonoscope because excessive pressure may cause the internal coil pipe assembly to detach, preventing proper angulation.
Integrated Medical Systems Inc is recalling nine Olympus CF-140L video colonoscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing proper angulation.
Integrated Medical Systems Inc is recalling 82 Olympus CF-Q180AL video colonoscopes because excessive pressure may cause the internal coil pipe to detach, preventing proper angulation.
Integrated Medical Systems Inc. is recalling 43 Olympus CF-Q160AL video colonoscopes because excessive pressure can cause the internal coil pipe to detach, preventing proper angulation.
Integrated Medical Systems Inc. is recalling nine Olympus GIF-Q140 video gastroscopes because excessive pressure can cause the internal coil pipe to detach, preventing proper angulation.
Integrated Medical Systems Inc is recalling 111 Olympus GIF-160 video gastroscopes because excessive pressure may cause the internal coil pipe assembly to detach, preventing proper angulation.
Integrated Medical Systems Inc. is recalling 185 Olympus GIF-Q180 video gastroscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing angulation from operating as intended.
Integrated Medical Systems Inc is recalling one Olympus video colonoscope because excessive pressure may cause the internal coil pipe to detach, affecting angulation.
Integrated Medical Systems Inc is recalling 275 Olympus GIF-H180 video gastroscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing proper angulation.