Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0842-2020 — Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

U.S. FDA — Device Enforcement · Finland · 2020-01-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0842-2020
Date of alert
2020-01-07
Country / jurisdiction
Finland
Risk level
Class II
Risk type
recall
Brand
Palodex Group Oy
Product category
device
Product type
Devices
Reported risk: Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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