Company: Radiometer America Inc
Date of Enforcement Report: 8/28/2019
Class II
PRODUCT
ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
- Recall Number: Z-2320-2019
REASON
Software Security; The action is being initiated because of software security vulnerabilities with the firm’s analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.
RECALLING FIRM/MANUFACTURER
Radiometer America Inc on 7/10/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
13,042 units
DISTRIBUTION
US Nationwide and International