Z-1776-2024 Class I Ongoing
FDA device recall Z-1776-2024 was initiated by Medtronic Navigation, Inc. on March 26, 2024 and is designated Class I. Reason for recall: Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation. The recall status is ongoing. Affected quantity: 3286 applications..
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2024
- Initiation Date
- March 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3286 applications.
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Republic Of Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, Nicaragua, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.