Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0067-04

Synchron CX4, CX5 and CX9 Pro Systems

Siemens Healthcare Diagnostics Inc. / initiated 2003-09-29 / Terminated

Beckman Coulter Inc began a recall of Synchron CX4, CX5 and CX9 Pro Systems on . The reason FDA records is "Motor driver boards may contain wrong type of microchip which does not have obstruction detection feature". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0067-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Healthcare Diagnostics Inc.
Product
Synchron CX4, CX5 and CX9 Pro Systems.
Product code
JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall
Motor driver boards may contain wrong type of microchip which does not have obstruction detection feature.
FDA root cause
Other
Action
Product Corrective Action letter was sent the week of 9/29/2003 by US MAIL with a fax back card.
Quantity in commerce
351
Distribution
Nationwide and Canada
Product codes and lots
NA