ClearanceBrief
Recall Z-0698-2007 ยท EQH Source, Carrier, Fiberoptic Light

Boston Scientific Corporation

Boston Scientific SpyGlass Light Cable Reference Number: 4621 UPN M00546210

DateMar 31, 2007 (initiated Feb 7, 2007)
StatusTerminated
ReasonLight Degradation in transmission-A film may deposit on the front face and limit transmission of light
Root causeOther
ActionBoston Scientific notified accounts by letter dated 2/1/07 requesting return of product.
Quantity13 units
DistributionNationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K864387LUXTEC FIBEROPTIC CABLES
Luxtec Corp., May 22, 1987