Health product recall

ATOMLAB 500 (2021-08-15)

Starting date:
August 15, 2021
Posting date:
September 17, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-76437



Last updated:
2021-09-17

Affected Products

ATOMLAB 500

Reason

Potential Atomlab 500 software error in custom Isotope module-when deleting Isotopes from custom isotope list, incorrect dial setting be assigned which can cause a measurement error. No other modules affected.  Default dial settings are correct.

Affected products

ATOMLAB 500

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

086-330

086-332

Companies
Manufacturer

BIODEX MEDICAL SYSTEMS INC

20 RAMSEY ROAD

SHIRLEY

New York

UNITED STATES