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.
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