Easy Access Software releases 1.1, 5.2, 6.2 & 7.2
This recall has been terminated (originally issued August 12, 2003).
- Company
- Philips Medical Systems
- Recall Initiated
- June 27, 2003
- Posted
- August 12, 2003
- Terminated
- January 12, 2005
- Recall Number
- Z-1125-03
- Quantity
- 46 devices
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
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.
Distribution
Devices were distributed to 23 hospitals and medical centers throughout the US.
Lot / Code Info
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
Root Cause
Other
Action Taken
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.