Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 13, 2018
fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone.
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
NordicNeuroLab As recalled fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signal… - a moderate-severity action.
fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signal… was recalled by NordicNeuroLab As in June 13, 2018. Reason: Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form t…. Check the official notice for the remedy. Verify recall #Z-2103-2018 with the FDA Devices before acting.
The recall
NordicNeuroLab As issued this moderate-severity FDA Devices recall-Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form t….
- Moderate
- severity level
- 64 units
- affected scope
- Class II
- classification
- June 13, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2103-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2103-2018) was formally reported on June 13, 2018, with the manufacturer initiating the action on October 28, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. NordicNeuroLab As is listed as the recalling firm, operating out of Bergen, N/A. Federal records list the affected scope as 64 units.
The documented reason for this recall is: Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and to the countries of : Russia, Israel. Norway, South Korea, China, France, South Africa, Japan, Poland, Chile, Switzerland. Australia, Belgium, Lithuania, United Kingdom and…. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 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
64 units
Related Recalls
6
3 from same agency
Product description
fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone.
Reason for recall
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2103-2018 |
| Date reported | June 13, 2018 |
| Date initiated | October 28, 2017 |
| Recalling firm | NordicNeuroLab As |
| Firm location | Bergen, N/A |
| Affected scope | 64 units |
| Distribution | Worldwide Distribution - USA (nationwide) and to the countries of : Russia, Israel. Norway, South Korea, China, France, South Africa, Japan, Poland, Chile, Switzerland. Australia, Belgium, Lithuania, United Kingdom and Bulgaria |
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-2103-2018) 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? ▼
fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone.. Recalled by NordicNeuroLab As. Units affected: 64 units.
Why was this product recalled? ▼
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 13, 2018. Severity: Moderate. Recall number: Z-2103-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and to the countries of : Russia, Israel. Norway, South Korea, China, France, South Africa, Japan, Poland, Chile, Switzerland. Australia, Belgium, Lithuania, United Kingdom and Bulgaria.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2103-2018) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 13, 2018. 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 July 2026.