Device product
Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
Z-2517-2021
Product summary
- Event
- Event 88401
- Status
- Terminated
- Classification
- Class II
- Quantity
- 114 units
- Official record key
device-enforcement:Z-2517-2021
Official wording
Reason: Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software
Code information: Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of Alabama, Florida, Massachusetts, Minnesota, Missouri, New York, Ohio, Texas, Virginia, Washington and the countries of AUSTRALIA, CHILE, UNITED KINGDOM, GEORGIA, ISRAEL, Mexico, NETHERLANDS, Portugal, Russia, Singapore, Thailand.
Derived failure modes
-
Unknown
Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software