Z-2642-2010

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

Name: Z-2642-2010 Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic...
Creator: Olympus America Inc.
Published: 2010-08-20
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2010-08-20 / Terminated / root cause: labeling and UDI

FDA source

Olympus America Inc. began a recall of Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment) on 2010-08-20. The reason FDA records is "Mislabeled. Endoscopic body-type camera heads labeled as cardiac-type". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2642-2010
Status: Terminated
Initiated: 2010-08-20
Posted: 2010-10-01
Terminated: 2012-09-27
Recalling firm: OLYMPUS Corporation of the Americas
Product: Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment)
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Mislabeled. Endoscopic body-type camera heads labeled as cardiac-type.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Asked consignees to return camera heads to correct the labeling.
Quantity in commerce: 217 camera heads
Distribution: nationwide; camera heads were serviced and returned to consignees in March 2003 - September 2007 timeframe
Product codes and lots: Models: OTV-S7H-1D-L08E and OTV-S7H-1D-F08E; serviced by recalling firm from 3/03 to 9/07

Product code GCJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)