FDA recall Z-2230-2019

Product

iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2

Reason for recall

Potential for iGUIDE to incorrectly monitor the 3D position.

Distribution

Nationwide distribution to AK, AL, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI. Worldwide distribution to Algeria, Argentina, Australia, Austria, Belgium, Botswana, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.

Key facts

Status

Terminated

Initiation date

2019-06-19

Report date

2019-08-21

Termination date

2024-05-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2230-2019