Reported Mar 5, 2014 · Terminated
The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which…
Instrumentarium Dental, PaloDEx Group Oy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Instrumentarium Dental, PaloDEx Group Oy · Nahkelantie 160 · Tuusula · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Device Model Number / Sales Code50600-IMG
- Serial Numbers (US and Foreign)
F21221 - F21641and F21643
- Serial Numbers (US Devices)
F21221 - F21230F21265 - F21270F21273 - F21290F21296 - F21350F23154 - F21365F21367 - F21391F21395 - F21447F21451 - F21464F21469 - F21478F21481 - F21486F21490 - F21519F21525 - F21542F21545 - F21550F21565 - F21588F21623 - F21628F21636 - F21641and F21643
- Amount recalled
- 101 units (US Distribution)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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