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 Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin Transmitter

FDA Recall Z-0709-06 · Posted 2006-04-07

Recalling FirmGE OEC Medical Systems,Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2006-02-06
Date Terminated2011-08-18
Product Quantity186 units

Reason for Recall

Small retaining pin may detach and fall into the surgical field during stereotactic surgery.

Firm Action

Consignees were notified by letter on 02/06/2006

Root Cause

Other

Distribution Pattern

AL, AZ, CA, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NJ, NV, NY, OR, PA, SC, TN, TX, UT, VA, WI, WV and one military facility in DC. Foreign distribution to Canada, Denmark, France Germany, Hong Kong, Italy, Japan, Switzerland, UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022069OEC FLUOROTRAK 9800 PLUSGe Oec Medical Systems · 2002-09-17K994270INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000Visualization Technology, Inc. · 2000-03-09K983529INSTATRAK 3000Visualization Technology, Inc. · 1998-12-31

Official Source

View FDA Recall →

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

↑