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

GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827.

FDA Recall Z-1713-2008 · Posted 2008-09-30

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeKPR
Date Initiated2007-03-29
Date Terminated2012-02-04
Product Quantity132

Reason for Recall

The actual average illuminance for the collimators are approximately 140-lux. This does not meet the 160-lux requirement. GE will be correcting the units by replacing all collimators.

Firm Action

GE will be correcting the units by replacing all collimators that don't meet the 160-lux requirement. The field correction will be initiated and is scheduled to be completed by October 2008.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution --- USA including states of CA, DE, FL, GA, ID, IL, KS, KY, MD, MI, MO, MT, NC, NJ, NM, NY, OH, PA, SC, TX, UT, VA, and WV, and countries of Australia, Canada, China, France, Germany, Greece, Italy, Korea, Poland, Saudi Arabia, United Kingdom, and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993090SILHOUETTE FCGe Medical Systems, Inc. · 1999-10-01

Official Source

View FDA Recall →

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

↑