Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1308-04

ViewForum Review Station Part Numbers: 9896 507 71830, 9896 507 71831, and 9896 507 71832

Philips North America LLC / initiated 2004-06-08 / Terminated

Philips Medical Systems Sales & Service Region No. America began a recall of ViewForum Review Station Part Numbers: 9896 507 71830, 9896 507 71831, and 9896 507 71832 on . The reason FDA records is "When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1308-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
ViewForum Review Station Part Numbers: 9896 507 71830, 9896 507 71831, and 9896 507 71832.
Product code
LLZ System, Image Processing, Radiological
Reason for recall
When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.
FDA root cause
Other
Action
The firm mailed letters via certified mail to their affected customers beginning on June 8, 2004. The letters instruct their customers to modify the default display on the ViewForum to exam/series date and time until a service representative can install the upgraded software R3.2.
Quantity in commerce
27
Distribution
Philips Medical Systems North American Company distributes product to medical facilities nationwide.
Product codes and lots
83616, 103380, 102578, 105315, 504608, 104095, 104900, 103620, 505119, 105295, 103540, 105735, 105608, 105493, 101585, 225694, 102492, 504979, 102101, 105290, 105486, 505784, 104079, 504925, 504952, 505815, 505960.