Solstice™ SRS Immobilization System CHS04Recalls & reported problems
Medtec, Inc. · Head support system for use with Type-S™ systems · Class 2
All models of Solstice SRS Immobilization System (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841439112496), received between Apr 16, 2019 and Apr 16, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 FDA recall record name this device's identifier.
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
- Apr 15, 2019Class IITerminated
There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
Z-1837-2019 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information1
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.
MalfunctionApr 16, 2019Insufficient Device Problem Information
USER SITE ON (B)(6) REPORTED BOWL MOVEMENT NOTED ON (B)(6) DURING PATIENT SETUP WHILE LOCK WAS ENGAGED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8519209 ↗
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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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