- #Soredex digora optime manual id15900 serial numbers#
- #Soredex digora optime manual id15900 serial number#
- #Soredex digora optime manual id15900 code#
The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF, KUWAIT, MALAYSIA, MALTA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, REPUBLIC OF CHINA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAMġ A record in this database is created when a firm initiates a correction or removal action. Palodex Group Oy as a manufacturer of the Imaging Plates Systems will take care of manufacturers reporting t Please communicate this information to your local distributors and report the initiated Medical Device Correction to your local authorities if the local regulation requires distributors to do so. As a result, Palodex Group OY is being proactive with our customers to have these identified Imaging Plates Systems corrected. Risk of fire or injury has been assessed to be low. The melting may generate smoke and eventually cause the PSU to fail. Slow degradation of plastic insulation used in the PSU DC plug may result in short circuiting which may cause heating and melting. In this letter we refer to DIGORA Optime, but instructions are applicable to all four makes listed in the table above.
#Soredex digora optime manual id15900 serial number#
Please Note: If the PSU serial number does not begin with 1143, 1221, 1224, or 1229, then no action is required.
#Soredex digora optime manual id15900 serial numbers#
Gendex GXPS-500: Serial Number Range GJ1209488 to GJ1311722ĭevices falling into these serial number ranges were delivered with PSUs having nine-digit serial numbers beginning with four digits as follows: Instrumentarium Dental Express: Serial Number Range IJ1208217 to IJ1313309 KaVo Scan eXam: Serial Number range KJ1208178 to KJ1314403 Soredex DIGORA Optime: Serial Number Range SJ1105219 to SJ1314421 The Power Supply Unit (PSU) delivered with the device may have a fault requiring correction. According to our records, we have delivered to you one or more devices belonging to the serial number range defined in the table below. Palodex Group OY has identified an issue with Soredex DIGORA Optime, KaVo Scan eXam, Instrumentarium Express, and Gendex GXPS-500 Imaging Plate Systems (later called IPS). On Januthe firm distributed Urgent Medical Device Recall Communication letters by letter stating: 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. Serial Number: TBD (range from KJ1208178 to KJ1314403) PSU's having nine-digit serial numbers beginning with four digits as follows: 1143XXXXX 1221XXXXX 1224XXXXX and 1229XXXXX KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
#Soredex digora optime manual id15900 code#
Solid state x-ray imager (flat panel/digital imager) - Product Code MQB Class 2 Device Recall KaVo Scan eXam (FLAT PANEL/DIGITAL IMAGER)
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