Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2580-2021 — Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.

U.S. FDA — Device Enforcement · United States · 2021-08-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2580-2021
Date of alert
2021-08-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Biodex Medical Systems, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
17081557
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.