Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1125-03

Easy Access Software releases 1.1, 5.2, 6.2 & 7.2

Philips North America LLC / initiated 2003-06-27 / Terminated

Philips Medical Systems began a recall of Easy Access Software releases 1.1, 5.2, 6.2 & 7.2 on . The reason FDA records is "If DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1125-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
Easy Access Software releases 1.1, 5.2, 6.2 & 7.2
Product code
LLZ System, Image Processing, Radiological
Reason for recall
If DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems.
FDA root cause
Other
Action
On 6/25/03 the firm issued a letter dated 6/15/03 to the affected customers. The letter advises of the problem and advises the customer that the firm will install corrected software in affected units.
Quantity in commerce
46 devices
Distribution
Devices were distributed to 23 hospitals and medical centers throughout the US.
Product codes and lots
The firm utilizes a site # to identify the devices: 83966, 82846, 82847,82843, 82845, 82850, 82849, 82844, 102836, 76904, 103125, 103124, 102835, 100640, 101185, 76938, 85078, 76937, 85083, 85077, 76904, 86255, 87121, 87120, 87119, 84399, 10276, 85052, 86190, 86050, X1758, X1676, 84031, 83966, 86002, 86001, X1776, 84476, 84088, 83676, 85451, 84361, 76945, 87130, 86198, 10379