FDA Medical Device Recalls (openFDA)
Olympus America Inc.: Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment)
- Recall number
- Z-2642-2010
- Recalling firm
- Olympus America Inc.
- Product
- Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment)
- Status
- Terminated
- Initiated
- 2010-08-20
- Posted
- 2010-10-01
- Terminated
- 2012-09-27
- Reason
- Mislabeled. Endoscopic body-type camera heads labeled as cardiac-type.
- Root cause
- Labeling mix-ups
- Action
- Asked consignees to return camera heads to correct the labeling.
- Quantity
- 217 camera heads
- Distribution
- nationwide; camera heads were serviced and returned to consignees in March 2003 - September 2007 timeframe
- Lot, serial or model codes
- Models: OTV-S7H-1D-L08E and OTV-S7H-1D-F08E; serviced by recalling firm from 3/03 to 9/07
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28