Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The FOCUS is a microprocessor controlled intra-oral x-ray unit with Recalled by Instrumentarium Dental, PaloDEx Group Oy Due to Instrumentarium Dental has delivered a number of FOCUS...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Instrumentarium Dental, PaloDEx Group Oy directly.
Affected Products
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.
Quantity: 101 units (US Distribution)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Instrumentarium Dental, PaloDEx Group Oy
Instrumentarium Dental, PaloDEx Group Oy has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report