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
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
