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Terminated

Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope

FDA Recall Z-0893-2016 · Posted None

Recalling FirmIntegrated Medical Systems Inc
Recall StatusTerminated
Product CodeGCQ
Date Initiated2016-01-20
Date Terminated2016-10-13
Product Quantity180 instruments

Reason for Recall

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.

Firm Action

The firm notified their consignees of the issue by Fed Ex on 01/20/2016. The firm plans to coordinate with the medical facilities for inspection of the endoscopes.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed US (nationwide) and in Australia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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