Reported Jun 5, 2013 · Terminated
Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102,…
Alpine Biomed Aps
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alpine Biomed Aps · 16-18 Tonsbakken · Skovlunde, N/A · N/A
Is this the product you have?
- Natus neurology Dantec KEYPOINT.NET 2.20
- Catalog/Part Numbers
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
- Product UsageDantec 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
- Lot codes and dates
- SERIAL NUMBERS
871 of 871 codes
30317220293607936063351823607021963219643006830240301702208322085302853028630288303233019230214302073032530106301682197121972300753021221760271730293303653600230193361212196236124303643508930045351013609021677303623524435209360913529736089350323530430167302903011030111360123038230410304113041230419
- SERIAL NUMBERS
- Amount recalled
- 871 licenses installed
Where it was sold
- Nationwide
Why it was recalled
Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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