T2 S-LINE AS 200 L
Received Jul 16, 2026
Report 9614977-2026-00110 · MDR key 25843312
Device
Generic name
Handpiece, Belt And/or Gear Driven, Dental
Manufacturer
Sirona Dental Systems GmbhProduct problems
- Overheating of Device
Patient
Unknown
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A T2 S-LINE AS 200 L OVERHEATED; PATIENT OUTCOME IS UNKNOWN.
Additional Manufacturer Narrative
THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.