ClearanceBrief
Recall Z-0067-04 ยท JQP Calculator/Data Processing Module, For Clinical Use

Beckman Coulter Inc

Synchron CX4, CX5 and CX9 Pro Systems.

DateOct 24, 2003 (initiated Sep 29, 2003)
StatusTerminated
ReasonMotor driver boards may contain wrong type of microchip which does not have obstruction detection feature.
Root causeOther
ActionProduct Corrective Action letter was sent the week of 9/29/2003 by US MAIL with a fax back card.
Quantity351
DistributionNationwide and Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K011465SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
Beckman Coulter, Inc., Jun 8, 2001
K951189SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0
Beckman Instruments, Inc., Jun 13, 1995