Modification to Focus

• • Terminated Z-1091-2014 FDA Class II ·initiated 14 Jan 2014

  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.

510(k) Number

K022630 ↗

FDA Product Code

EHD

Device Class

Class II

Regulation

21 CFR Part 872.1800

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Instrumentarium Corp. →