Drug recall
The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC…
FDA recall event 67342 · Class II · Instrumentarium Dental, PaloDEx Group Oy
Key facts
| Event ID | 67342 |
|---|---|
| Recall numbers | Z-1091-2014 |
| Recalling firm | Instrumentarium Dental, PaloDEx Group Oy |
| Product type | Devices |
| 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jan 14, 2014 |
| Report date | Mar 5, 2014 |
| Termination date | May 22, 2015 |
| City | Tuusula |
| Country | Finland |
| FEI number | 3005383085 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: