Recall Z-2580-2021— Biodex Medical Systems, Inc.

Name: FDA recall Z-2580-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-16

Class II · Terminated

Class II FDA medical device recall by Biodex Medical Systems, Inc., initiated 2021-08-16, terminated 2024-05-30. It names one FDA 510(k) clearance: K090296. Product: Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.. Reason: 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.

Recalling firm: Biodex Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-08-16
Terminated: 2024-05-30
Firm location: Shirley, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K090296 — ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336Biodex Medical Systems, Inc.·cleared 2009-02-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.