CranialMask Tracker 6000-390-000Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · CranialMask Tracker · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327097627), received between Jun 4, 2018 and Jul 19, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Image Display Error/Artifact” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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 18, 2026.
Recalls naming this device
- Nov 12, 2025Class IIOpen, Classified
When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.
Z-0963-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Image Display Error/Artifact1
- Image Orientation Incorrect1
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 19, 2022Incorrect Measurement; Incorrect Measurement
PER THE SURGEON, THE PRODUCT WAS NOT ACCURATE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15059945 ↗MalfunctionJun 4, 2018Image Display Error/Artifact; Image Orientation Incorrect; Image Display Error/Artifact; Image Orientation Incorrect
IT WAS REPORTED THAT DURING SETUP PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE REGISTRATION WAS NOT ACCURATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7565174 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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