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Terminated

Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment)

FDA Recall Z-2642-2010 · Posted 2010-10-01

Recalling FirmOlympus America Inc.
Recall StatusTerminated
Product CodeGCJ
Date Initiated2010-08-20
Date Terminated2012-09-27
Product Quantity217 camera heads

Reason for Recall

Mislabeled. Endoscopic body-type camera heads labeled as cardiac-type.

Firm Action

Asked consignees to return camera heads to correct the labeling.

Root Cause

Labeling mix-ups

Distribution Pattern

nationwide; camera heads were serviced and returned to consignees in March 2003 - September 2007 timeframe

Official Source

View FDA Recall →

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

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