FDA Medical Device Recalls (openFDA)
Vision Systems Group, A Div of Viking Systems: Light Source 300 Watt Xenon Lamp used in the following models: Viking EndoSite Xenon, Model 8050-1 and Boston Scientific Spyglass 300W Light Source (M00546190)
- Recall number
- Z-0873-2007
- Recalling firm
- Vision Systems Group, A Div of Viking Systems
- Product
- Light Source 300 Watt Xenon Lamp used in the following models: Viking EndoSite Xenon, Model 8050-1 and Boston Scientific Spyglass 300W Light Source (M00546190)
- Status
- Terminated
- Initiated
- 2007-04-05
- Posted
- 2007-06-06
- Terminated
- 2007-06-07
- Reason
- Incorrect power entry module assembled into unit may cause burning to insulation, compromised electrical emissions and premature light source failure
- Root cause
- Nonconforming Material/Component
- Action
- Viking notified 2 distributors and 1 end user by telephone on 3/15/07. Viking representatives performed on site visit to perform inspection and replace units if needed.
- Quantity
- 4
- Distribution
- Nationwide to CA and NC
- Lot, serial or model codes
- Units manufactured from 1/23/07 through 3/14/07 with serial numbers: 120906, 016707, 016907, 017007
- 510(k) numbers
- ["K864385"]
- PMA numbers
- not on file
- Product code
- KOG
- Firm FEI
- 1000305720
- Firm city
- Westborough
- Firm state
- MA
- 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