Palodex Group Oy: KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Recall number

Z-0841-2020

Recalling firm

Palodex Group Oy

Product

KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Status

Terminated

Initiated

2020-01-07

Posted

not on file

Terminated

2024-04-15

Reason

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.

Root cause

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

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

Lot, serial or model codes

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

510(k) numbers

["K041050"]

PMA numbers

not on file

Product code

MQB

Firm FEI

3005383085

Firm city

Tuusula

Firm state

not on file

Firm country

Finland

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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