Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 5, 2013
Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, 9031A0032, 9033A0517, 9033A072101, 9031A0031, 9031A0701BV, 9033A0044, 9033A0073AA, 9031A0063, 9033A0523, 9033A071143, 9033A072143, 9031A006406, 9031A006506, 9031A070106, 9033A004606 9033A004706, 9033A007406, 9033A0537, 9033A0544, 9033A
Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug.
The recall
Alpine Biomed Aps issued this moderate-severity FDA Devices recall — Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of ….
- Moderate
- severity level
- 871 licenses installed
- units affected
- Class II
- classification
- June 5, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1407-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1407-2013) was formally reported on June 5, 2013, with the manufacturer initiating the action on April 9, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Alpine Biomed Aps is listed as the recalling firm, operating out of Skovlunde, N/A. Federal records indicate 871 licenses installed units are affected.
The documented reason for this recall is: Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and the countries of: Germany, France, Bulgaria, India, Colombia, Tunisia, Saudi Arabia, Finland, Denmark, Brasil, Italy, Estonia, South Korea, Russia, Greece, Thailand, Israel, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Where this recall sits in the database
Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.
Units Affected
871 licenses installed
Related Recalls
6
6 from same agency
Product Description
Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, 9031A0032, 9033A0517, 9033A072101, 9031A0031, 9031A0701BV, 9033A0044, 9033A0073AA, 9031A0063, 9033A0523, 9033A071143, 9033A072143, 9031A006406, 9031A006506, 9031A070106, 9033A004606 9033A004706, 9033A007406, 9033A0537, 9033A0544, 9033A071106, 9033A072106, 9033A0524, 9033A0711BV, 9033A007401, 9033A0516, 9031A006403, 9031A006503, 9033A056403, 9033A0721BV, 9031A006402, 9031A006405, 9031A051306, 9031A070105, 9033A0072, 9033A007301, 9033A0711AA, 9033A0721AA Product Usage: Dantec KEYPOINT.NET Software 2.20 is installed on the Keypoint EMG System which is intended as an electro-physiological aid to assess diagnosis and prognosis and to monitor diseases of the central and peripheral nervous system. It can also be used to study functional aspects of nerves and muscles.
Reason for Recall
Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug.
Details
- Recalling Firm
- Alpine Biomed Aps
- Units Affected
- 871 licenses installed
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Germany, France, Bulgaria, India, Colombia, Tunisia, Saudi Arabia, Finland, Denmark, Brasil, Italy, Estonia, South Korea, Russia, Greece, Thailand, Israel, Poland, Turkey, Slovakia, Portugal, Switzerland, Hungary, Great Britain, Netherlands, China, Indonesia, Australia, Sweden, Spain, Iran, Singapore, Norway, Austria and Czech Republic.
- Location
- Skovlunde, N/A
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1407-2013 |
| Date reported | June 5, 2013 |
| Date initiated | April 9, 2013 |
| Recalling firm | Alpine Biomed Aps |
| Units affected | 871 licenses installed |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Germany, France, Bulgaria, India, Colombia, Tunisia, Saudi Arabia, Finland, Denmark, Brasil, Italy, Estonia, South Korea, Russia, Greece, Thailand, Israel, Poland, Turkey, Slov… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, 9031A0032, 9033A0517, 9033A072101, 9031A0031, 9031A0701BV, 9033A0044, 9033A0073AA, 9031A0063, 9033A0523, 9033A071143, 9033A072143, 9031A006406, 9031A006506, 9031A070106, 9033A004606 9033A004706, 9033A007406, 9033A0537, 9033A0544, 9033A071106, 9033A072106, 9033A0524, 9033A0711BV, 9033A007401, 9033A0516, 9031A006403, 9031A006503, 9033A056403, 9033A0721BV, 9031A006402, 9031A006405, 9031A051306, 9031A070105, 9033A0072, 9033A007301, 9033A0711AA, 9033A0721AA Product Usage: Dantec KEYPOINT.NET Software 2.20 is installed on the Keypoint EMG System which is intended as an electro-physiological aid to assess diagnosis and prognosis and to monitor diseases of the central and peripheral nervous system. It can also be used to study functional aspects of nerves and muscles.. Recalled by Alpine Biomed Aps. Units affected: 871 licenses installed.
Why was this product recalled? ▼
Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2013. Severity: Moderate. Recall number: Z-1407-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide and the countries of: Germany, France, Bulgaria, India, Colombia, Tunisia, Saudi Arabia, Finland, Denmark, Brasil, Italy, Estonia, South Korea, Russia, Greece, Thailand, Israel, Poland, Turkey, Slovakia, Portugal, Switzerland, Hungary, Great Britain, Netherlands, China, Indonesia, Australia, Sweden, Spain, Iran, Singapore, Norway, Austria and Czech Republic..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1407-2013) 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 June 5, 2013.
- 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.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).