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Olympus Corporation of the Americas Recall 90232

Description: EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190

Olympus Corporation of the Americas Recall 90232 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1275-2022
Event ID90232
Event DescriptionEVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
Product TypeDevices
DistributionUS Nationwide distribution in the states of AL, FL, NC, NY.
Quantity8 units
Recall ReasonPart (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
Device Classification20220629
Device Code InfoUDI-DI: 04953170305276 Serial: 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773 and 2962545
Center Classification Date20220621
Recall Initiation Date20220422
Recalling FirmOlympus Corporation of the Americas
Initial Notification E-Mail
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