Reported Oct 6, 2021 · Terminated
Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
Biodex Medical Systems, Inc.
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: Biodex Medical Systems, Inc. · 20 Ramsey Rd · Shirley, NY · 11967-4704
Is this the product you have?
- Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08
- inclusive Model086-330
- Lot codes and dates
- Serial Number range17081557-21062362
- UDI00718175003305
- Amount recalled
- 829 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration
This product could cause temporary or reversible health problems — stop using it.
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