The FOCUS is a microprocessor controlled intra-oral x-ray unit with a… — Class II medical device recall Z-1091-2014
Terminated recall by Instrumentarium Dental, PaloDEx Group Oy, reported 2014-03-05, distributed nationwide. Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray units in November 2013 with a poten
| Recall number | Z-1091-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentarium Dental, PaloDEx Group Oy, Tuusula, Finland |
| Recall initiated | 2014-01-14 |
| Classified | 2014-02-25 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2015-05-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BR, CH, CL, CN, CZ, DE, ES, FR, GB, IT, SE |
| Quantity | 101 units |
| Serial numbers | F21221, F21230, F21265, F21270, F21273, F21290, F21296, F21350, F21365, F21367, F21391, F21395, F21447, F21451, F21464, F21469, F21478, F21481, F21486, F21490, F21519, F21525, F21542, F21545, F21550 and 8 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1091-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.