Events

Recall of Device Recall FOCUS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Instrumentarium Dental, PaloDEx Group Oy.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67342
  • Event Risk Class
    Class 2
  • Event Number
    Z-1091-2014
  • Event Initiated Date
    2014-01-14
  • Event Date Posted
    2014-02-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125292
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Unit, x-ray, extraoral with timer - Product Code EHD
  • Reason
    Instrumentarium dental has delivered a number of focus 3.0 intraoral x-ray units in november 2013 with a potential flaw in the mounting hardware. a number of wall mount units were delivered with focus x-ray machines that had not been properly welded at our supplier. as a result of the incomplete welding operation, the wall mount unit on the focus x-ray unit may not properly support the unit as exp.
  • Action
    The firm, Instrumentarium, sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 14, 2014 was sent to all PaloDEx direct accounts (including subsidiaries). The letter inested recipients to perform a field inspection on potentially defective FOCUS 3.0 X-ray units (units with serial numbers F21221 - F21641 and F21643). If a defective wall mount is discovered during the inspection, the FOCUS X-ray unit must be taken out of service and the wall mount replaced before continuing use of the device. Replacement wall mounts will be made available free of charge for the field repair. A Technical Bulletin including instructions on how to perform the inspection was included with the letter. Direct accounts were further instructed to return the enclosed Acknowledgement Letter confirming receipt of the URGENT MEDICAL DEVICE RECALL letter by mail to Instrumentarium Dental, Jussi Tanskanen, Nahkelantie 160, Fl-04300 Finland; or, via e-mail to Jussi.tanskanen@instrudental.com. The direct accounts are to complete and return the enclosed Confirmation Letter to document that all of the potentially affected units have been inspected and repaired if necessary to Instrumentarium Dental, Jussi Tanskanen, Nahkelantie 160, Fl-04300 Finland; or, via e-mail to Jussi.tanskanen@instrudental.com. A nearly identical URGENT MEDICAL DEVICE RECALL letter dated January 22, 2014 was sent to all US customers. The instructions were the same as noted above in the January 14, 2014 letter to PaloDEx direct accounts. If there are any questions, do not hesitate to contact us at the following: Marketing Director, General dentistry Mika.anttila@instrudental.com Tel. +358 40 768 3340 For more information you can contact also: Director, Quality and Regulatory Affairs Tarja.paivinen@instrudental.com Tel. +358 40 719 0513 After sales Manager Mika.Kyllonen@instrudental.com Tel. + 358 40 080 5305

Device

Device Recall FOCUS
  • Model / Serial
    Device Model Number / Sales Code: 50600-IMG;   Serial Numbers (US and Foreign): F21221 - F21641, and F21643;   Serial Numbers (US Devices): F21221 - F21230, F21265 - F21270, F21273 - F21290, F21296 - F21350, F23154 - F21365, F21367 - F21391, F21395 - F21447, F21451 - F21464, F21469 - F21478, F21481 - F21486, F21490 - F21519, F21525 - F21542, F21545 - F21550, F21565 - F21588, F21623 - F21628, F21636 - F21641, and F21643
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) including states of: AK, AZ, CA, CO, GA, IL, KY, MD, MT, NC, NV, OR, PA, TN, TX, UT, VA, WA,and WI; and Internationally to: Belgium Brazil, Chile, China, Czech Republic, France, Germany, Italy, Spain, Sweden, Switzerland, and United Kingdom.
  • Product Description
    The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm. || FOCUS is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
  • Manufacturer
    Instrumentarium Dental, PaloDEx Group Oy

Manufacturer

Instrumentarium Dental, PaloDEx Group Oy
  • Manufacturer Address
    Instrumentarium Dental, PaloDEx Group Oy, Nahkelantie 160, Tuusula Finland
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA