WayPoint™ Planner 66-WP-PL-00437Recalls & reported problems
Fhc, Inc. · microTargeting WayPoint Planner Software, single license · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00873263004371), received between Sep 27, 2017 and Sep 27, 2017 — classified as 1 malfunction.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SURGEON REPORTED TO FHC'S TECHNICAL SUPPORTIVE REPRESENTATIVE REGARDING IMAGE REGISTRATION IN WAYPOINT PLANNER (66-WP-PL). THE PATIENT WAS PREVIOUSLY INSTALLED WITH BONE ANCHORS AND HAD UNDERGONE CT AND MRI SCAN. THE SURGEON DID NOT LIKE THE IMAGE REGISTRATION WITH WAYPOINT PLANNER (66-WP-PL) AND DECIDED TO USE A FRAME FOR THE PATIENT. THREE SCANS WERE AVAILABLE FOR REVIEW; CT WITH ANCHORS, MRI AND CT WITH ANCHORS AND FRAME. THE CT WITH ANCHORS AND CT WITH ANCHORS AND FRAME MERGED VERY WELL. THE CT TO MRI SHOWED AC AND PC TO BE MORE THAN A MILLIMETER OFF. AS A RESULT OF THIS, SURGEON DECIDED TO RESCHEDULE THE SURGERY. THERE WAS NO EVIDENCE THAT THE PATIENT WAS HARMED IN ANYWAY BY RESCHEDULING THE SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6897451 ↗
Other Neurological stereotaxic Instrument devices
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument4 deaths4,668 reports
- Stealthstation® S7™ 9733856Medtronic Navigation, Inc. · Neurological stereotaxic Instrument6 deaths3,908 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death1,896 reports
- StealthStation S8 9735669Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1,831 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument2 deaths1,542 reports
- Fusion™ ENT Image Guidance System 9733560XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument1,316 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument8 deaths984 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death695 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page