Instrumentarium Dental, Palodex Group Oy
FinlandFDA applicant, unverified
- Devices
- 5
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Sigma M Ref K063837
Regimes: 510(k) Registry: 510(k)Orthopantomograph OP300 Ref K093683
Regimes: 510(k) Registry: 510(k)Digora Optime Ref K133231
Regimes: 510(k) Registry: 510(k)Orthopantomograph OP30 Ref K092591
Regimes: 510(k) Registry: 510(k)Snapshot Ref K081925
Regimes: 510(k) Registry: 510(k)
FDA recalls
2014
- 14 Jan 2014 Z-1091-2014 Class II Terminated 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.
Full distribution text
- 14 Jan 2014 Z-1091-2014 Class II Terminated 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.
Frequently asked questions
How many devices does Instrumentarium Dental, Palodex Group OY have in the registry?
The registry currently lists 5 devices for Instrumentarium Dental, Palodex Group OY. Devices recorded under merged duplicate company entries are counted once.
Which registries list Instrumentarium Dental, Palodex Group OY's devices?
Among its 5 most recently registered devices, Instrumentarium Dental, Palodex Group OY has devices listed in FDA 510(k) (5 devices).
What risk classes do Instrumentarium Dental, Palodex Group OY's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Instrumentarium Dental, Palodex Group OY's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Instrumentarium Dental, Palodex Group OY?
FDA recall records list 1 recall initiated by Instrumentarium Dental, Palodex Group OY, the most recent initiated on 14 Jan 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Instrumentarium Dental, Palodex Group OY in the registry?
The most recently registered devices listed for Instrumentarium Dental, Palodex Group OY include SIGMA M, ORTHOPANTOMOGRAPH OP300, DIGORA OPTIME and ORTHOPANTOMOGRAPH OP30.