T2 LINE A 200 L
Received Jul 20, 2026
Report 9614977-2026-00117 · MDR key 25882662
Device
Generic name
Handpiece, Belt And/or Gear Driven, Dental
Manufacturer
Sirona Dental Systems GmbhCatalog number
6376177
Product problems
- Overheating of Device
Patient
Unknown
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A T2 LINE A 200 L HANDPIECE GETS HOT. THE EVENT OUTCOME IS UNKNOWN AS OF THIS REPORT.
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.ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME HAS BEEN REQUESTED AND WILL BE SUBMITTED AS IT BECOMES AVAILABLE.