Z-2230-2019 Class II Terminated
FDA device recall Z-2230-2019 was initiated by Elekta, Inc. on June 19, 2019 and is designated Class II. Reason for recall: Potential for iGUIDE to incorrectly monitor the 3D position. The recall status is terminated (terminated May 6, 2024). Affected quantity: 374 devices.
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2019
- Initiation Date
- June 19, 2019
- Termination Date
- May 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 374 devices
Product Description
Reason for Recall
Distribution Pattern
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.