ClearanceBrief
Recall Z-0804-03 ยท

Misys Healthcare Systems

Misys Laboratory System versions 5.23 and 5.3

DateMay 9, 2003 (initiated Mar 27, 2003)
StatusTerminated
ReasonSoftware anomaly.
Root causeOther
ActionThe firm sent notification of the situation in Product Safety Notice PSN-03-L14 by fax on 3/27/2003. It communicated a workaround solution and informed of an impending code addition intended to be made available at a future date.
Quantity463
DistributionNationwide and to United Kingdom, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, United Arab Emirates,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.