FDA Device

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

Hazard

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

What You Should Do

Remedy

Asked consignees to return camera heads to correct the labeling.

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Products

Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment)
Brand
Olympus America Inc.
UPC
Models: OTV-S7H-1D-L08E and OTV-S7H-1D-F08E; serviced by recalling firm from 3/03 to 9/07

Units Affected

217 camera heads

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