ClearanceBrief
Recall Z-0985-02 ยท

Multidata Systems Intl Corp

Block Mold Cutter, Model 8532, Version 1.2.

DateSep 13, 2003 (initiated Nov 10, 2002)
StatusTerminated
ReasonThe units lacked the required labels per the laser performace standard.
Root causeOther
Quantity10 units
DistributionDistribution was made to SC, FL, GA, NY, PA, NC, IL, and NJ.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K964167DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY)
Multidata Systems International Corp., Mar 21, 1997