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U.S. Department of Health and Human Services

Class 2 Device Recall Instrumentarium Dental Express (FLAT PANEL/DIGITAL IMAGER)

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  Class 2 Device Recall Instrumentarium Dental Express (FLAT PANEL/DIGITAL IMAGER) see related information
Date Initiated by Firm January 07, 2020
Create Date January 24, 2020
Recall Status1 Terminated 3 on April 15, 2024
Recall Number Z-0842-2020
Recall Event ID 84544
510(K)Number K041050  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Code Information Serial Number: TBD (range from IJ1208217 to IJ1313309)  PSU's having nine-digit serial numbers beginning with four digits as follows: 1143XXXXX 1221XXXXX 1224XXXXX and 1229XXXXX
Recalling Firm/
Manufacturer		 Palodex Group Oy
Nahkelantie 160
Tuusula Finland
For Additional Information Contact
358-40-5121967
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Component design/selection
Action On January 7, 2020 the firm distributed Urgent Medical Device Recall Communication letters by letter stating: Urgent Medical Device Correction Dear KaVo Kerr Customer, 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). According to our records, we have delivered to you one or more devices belonging to the serial number range defined in the table below. The Power Supply Unit (PSU) delivered with the device may have a fault requiring correction. Product Soredex DIGORA Optime: Serial Number Range SJ1105219 to SJ1314421 KaVo Scan eXam: Serial Number range KJ1208178 to KJ1314403 Instrumentarium Dental Express: Serial Number Range IJ1208217 to IJ1313309 Gendex GXPS-500: Serial Number Range GJ1209488 to GJ1311722 Devices falling into these serial number ranges were delivered with PSUs having nine-digit serial numbers beginning with four digits as follows: 1143XXXXX 1221XXXXX 1224XXXXX and 1229XXXXX Please Note: If the PSU serial number does not begin with 1143, 1221, 1224, or 1229, then no action is required. In this letter we refer to DIGORA Optime, but instructions are applicable to all four makes listed in the table above. Issue Description Slow degradation of plastic insulation used in the PSU DC plug may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail. Risk of fire or injury has been assessed to be low. As a result, Palodex Group OY is being proactive with our customers to have these identified Imaging Plates Systems corrected. 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. Palodex Group Oy as a manufacturer of the Imaging Plates Systems will take care of manufacturers reporting t
Quantity in Commerce 4,563 Total Globally (all products)
Distribution US: WI and PA 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, VIETNAM
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. 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. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = SOREDEX PALODEX GROUP OY
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