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

OSI, Allegro 6800 Imaging Table (Operating), single pedestal AC or battery operated table, Orthopedic Systems, Inc., Union City, CA

FDA Recall Z-0241-2008 · Posted 2007-12-13

Recalling FirmMizuho Orthopedic Systems Inc
Recall StatusTerminated
Product CodeLHN
Date Initiated2007-02-28
Date Terminated2008-12-18
Product Quantity117 units

Reason for Recall

Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.

Firm Action

The firm issued a Product Correction Notification letter by mail on 02/28/2007 and follow up with phone calls. The letter notified users that a required no-cost upgrade of the removal and replacement of a microprocessor that controls the logic for the floor locking mechanism will be conducted by the recalling firm.

Root Cause

Software design

Distribution Pattern

Worldwide: USA product was distributed to 16 wholesale dealers, 212 medical facilities, 14 distributors throughout the US in the following states: AL, AZ, CA, FL, GA, HI, IL, IN, KS, KY, MA, MD, ME, MI, MO, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, TX, VA, WA, WI, WV and WY and to the following countries Taiwan, Australia, German, Japan, Canada, Saudi Arabia, and The UK.

Official Source

View FDA Recall →

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

↑