Medtronic Navigation, Inc Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460 (software version 3.0) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460 (software version 3.0)
Brand
Medtronic Navigation, Inc
Lot Codes / Batch Numbers
System Serial Numbers: 103, 104, 109, 117, 119 (Germany) 125, and 144 (Canada)
Products Sold
System Serial Numbers: 103, 104, 109, 117, 119 (Germany) 125, and 144 (Canada)
Medtronic Navigation, Inc is recalling Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Li due to Reversed Instrument Position : a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are re. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reversed Instrument Position : a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180' on the StealthStation image. (If the StealthStation is not used, or if the patient orientation is prone or supine, the problem does not occur)
Recommended Action
Per FDA guidance
Medtronic Navigation notified customers by letter on October 17, 2007. Medtronic Field service will perform upgrade (software version 3.0.1) at user site.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, IN, MN, NE
Page updated: Jan 10, 2026