Solstice SRS Immobilization SystemRecalls & reported problems across all models

We found 2 models of Solstice SRS Immobilization System by Medtec, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, 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 at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Solstice SRS Immobilization System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 15, 2019Terminated

   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 · names 2 of these models · Recall details · FDA record ↗

Most reported Solstice SRS Immobilization System problems

Solstice SRS Immobilization System models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Solstice™ SRS Immobilization System CHS04

  Accelerator, linear, medical
  1 recall1 report
• Solstice™ SRS Immobilization System CHS03

  Accelerator, linear, medical
  1 recall0 reports

Recent Solstice SRS Immobilization System adverse event reports

The 1 most recent reports across all models, 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 ↗