Recall Z-1091-2014— Instrumentarium Dental, PaloDEx Group Oy

Name: FDA recall Z-1091-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-14

Class II · Terminated

Class II FDA medical device recall by Instrumentarium Dental, PaloDEx Group Oy, initiated 2014-01-14, terminated 2015-05-22. It names one FDA 510(k) clearance: K022630. 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.. Reason: 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..

Recalling firm: Instrumentarium Dental, PaloDEx Group Oy
Classification: Class II
Status: Terminated
Initiated: 2014-01-14
Terminated: 2015-05-22
Firm location: Tuusula, Finland

510(k) clearances named in this recall

1 on FDA's record

K022630 — MODIFICATION TO FOCUSInstrumentarium Corp.·cleared 2002-10-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.