Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Boston Scientific SpyGlass Light Cable Reference Number: 4621 UPN M00546210

FDA Recall Z-0698-2007 · Posted 2007-03-31

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeEQH
Date Initiated2007-02-07
Date Terminated2007-11-15
Product Quantity13 units

Reason for Recall

Light Degradation in transmission-A film may deposit on the front face and limit transmission of light

Firm Action

Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.

Root Cause

Other

Distribution Pattern

Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K864387LUXTEC FIBEROPTIC CABLESLuxtec Corp. · 1987-05-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑