Z-1091-2014Class II

The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC...

Name: Z-1091-2014 The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC...
Creator: Instrumentarium Dental, PaloDEx Group Oy
Published: 2014-01-14
License: https://open.fda.gov/license/

Palodex Group Oy / initiated 2014-01-14 / Terminated / root cause: design

FDA source

Instrumentarium Dental, PaloDEx Group Oy began a recall of 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... on 2014-01-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1091-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-14
Posted: 2014-02-25
Terminated: 2015-05-22
Recalling firm: Palodex Group Oy
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.
Product code: EHD Unit, X-Ray, Extraoral With Timer
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.
Root cause tag: design
FDA root cause: 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 [email protected]. 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 [email protected]. 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 [email protected] Tel. +358 40 768 3340 For more information you can contact also: Director, Quality and Regulatory Affairs [email protected] Tel. +358 40 719 0513 After sales Manager [email protected] 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1091-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1091-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-25

Product code EHD

K022630Class IIModification to FocusInstrumentarium Corp. / cleared 2002-10-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)