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U.S. Department of Health and Human Services

Class 2 Device Recall FOCUS

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  Class 2 Device Recall FOCUS see related information
Date Initiated by Firm January 14, 2014
Date Posted February 25, 2014
Recall Status1 Terminated 3 on May 22, 2015
Recall Number Z-1091-2014
Recall Event ID 67342
510(K)Number K022630  
Product Classification Unit, x-ray, extraoral with timer - Product Code EHD
Product 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.
Code Information 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
Recalling Firm/
Instrumentarium Dental, PaloDEx Group Oy
Nahkelantie 160
Tuusula Finland
For Additional Information Contact Mr. Frank Kashinski
Manufacturer Reason
for Recall
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 expected, which could cause the unit to drift. Depending on the extent of the shortened or missing welds, there is also a possibility that the wall mount unit will fail to support the weight of the unit, resulting in the FOCUS X-ray unit falling unexpectedly from its mounted position.
FDA Determined
Cause 2
Device Design
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
Quantity in Commerce 101 units (US Distribution)
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.
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 = EHD and Original Applicant = INSTRUMENTARIUM CORP.