Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 5, 2014
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
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…
Instrumentarium Dental, PaloDEx Group Oy recalled The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequ… — a moderate-severity action.
The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequ… was recalled by Instrumentarium Dental, PaloDEx Group Oy in March 5, 2014. Reason: Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray units in November 2013 with a pote…. Check the official notice for the remedy. Verify recall #Z-1091-2014 with the FDA Devices before acting.
The recall
Instrumentarium Dental, PaloDEx Group Oy issued this moderate-severity FDA Devices recall — Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray units in November 2013 with a pote….
- Moderate
- severity level
- 101 units
- affected scope
- Class II
- classification
- March 5, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1091-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1091-2014) was formally reported on March 5, 2014, with the manufacturer initiating the action on January 14, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Instrumentarium Dental, PaloDEx Group Oy is listed as the recalling firm, operating out of Tuusula. Federal records list the affected scope as 101 units (US Distribution).
The documented reason for this recall is: 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 tha… Distribution data in the federal record shows the product reached: Worldwide Distribution: US (Nationwide) including states of: AK, AZ, CA, CO, GA, IL, KY, MD, MT, NC, NV, OR, PA, TN, TX, UT, VA, WA,and WI; and Internationally to: Belgium Brazil, Chile, China, Czech Republic, France, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
101 units (US Distribution)
Related Recalls
6
6 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1091-2014 |
| Date reported | March 5, 2014 |
| Date initiated | January 14, 2014 |
| Recalling firm | Instrumentarium Dental, PaloDEx Group Oy |
| Firm location | Tuusula |
| Affected scope | 101 units (US Distribution) |
| Distribution | Worldwide Distribution: US (Nationwide) including states of: AK, AZ, CA, CO, GA, IL, KY, MD, MT, NC, NV, OR, PA, TN, TX, UT, VA, WA,and WI; and Internationally to: Belgium Brazil, Chile, China, Czech Republic, France, Germany, Italy, Spai… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1091-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Instrumentarium Dental, PaloDEx Group Oy. Units affected: 101 units (US Distribution).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2014. Severity: Moderate. Recall number: Z-1091-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (Nationwide) including states of: AK, AZ, CA, CO, GA, IL, KY, MD, MT, NC, NV, OR, PA, TN, TX, UT, VA, WA,and WI; and Internationally to: Belgium Brazil, Chile, China, Czech Republic, France, Germany, Italy, Spain, Sweden, Switzerland, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1091-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported March 5, 2014.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.