—#27814

Product

Easy Access Software releases 1.1, 5.2, 6.2 & 7.2

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K983447
Affected 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

Why it was recalled

If DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems
Address: 22100 Bothell Everett Highway, Bothell, Washington 98041

Distribution

Distribution pattern: Devices were distributed to 23 hospitals and medical centers throughout the US.

Timeline

Recall initiated: 2003-06-27
Posted by FDA: 2003-08-12
Terminated: 2005-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #27814. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.