Instrumentarium Dental FOCUS 3.0 Intraoral X-ray Units Recalled for Mounting Flaw
Instrumentarium Dental is recalling FOCUS 3.0 intraoral x-ray units due to incomplete welding in the wall mount hardware, which could cause the unit to drift or fall.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in the mounting hardware that could result in the x-ray unit falling unexpectedly, which aligns with the rubric criteria for 'structural vehicle defect' or 'significant injury/property-damage reports' (interpreted as a significant physical hazard).
Plain-English summary
Instrumentarium Dental, PaloDEx Group Oy, is recalling FOCUS 3.0 intraoral x-ray units delivered in November 2013. The recall involves 101 units distributed in the United States and internationally. The affected devices are microprocessor-controlled units used for producing diagnostic x-ray radiographs of dentition, jaws, and other oral structures.
The recall is due to a potential flaw in the mounting hardware. Some wall mount units were delivered with x-ray machines that had not been properly welded at the supplier. This incomplete welding operation may prevent the wall mount unit from properly supporting the x-ray unit as expected, which could cause the unit to drift. Depending on the extent of the shortened or missing welds, the wall mount unit may fail to support the weight of the unit, resulting in the FOCUS x-ray unit falling unexpectedly from its mounted position.
Affected serial numbers for US devices include F21221 - F21230, F21265 - F21270, F21273 - F21290, F21296 - F21350, F23154 - F21365, F21367 - F21391, F21395 - F21447, F21451 - F21464, F21469 - F21478, F21481 - F21486, F21490 - F21519, F21525 - F21542, F21545 - F21550, F21565 - F21588, F21623 - F21628, F21636 - F21641, and F21643. The device model number is 50600-IMG. The source text does not specify specific consumer actions beyond the recall context.
The recalled product
- 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…
- Manufacturer
- Instrumentarium Dental, PaloDEx Group Oy
- Category
- Medical Device — Dental Imaging
- Affected units
- 101
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- Device Model Number / Sales Code: 50600-IMG
- Serial Numbers (US and Foreign): F21221 - F21641
- and F21643
- Serial Numbers (US Devices): F21221 - F21230
- F21265 - F21270
- F21273 - F21290
- F21296 - F21350
- F23154 - F21365
- F21367 - F21391
- F21395 - F21447
- F21451 - F21464
- F21469 - F21478
- F21481 - F21486
- F21490 - F21519
- F21525 - F21542
- F21545 - F21550
- F21565 - F21588
- F21623 - F21628
- F21636 - F21641
Distribution
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