—#46986

Product

Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with Multi Planar Reformat (MPR) Option

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033088
Affected lot / code info: PACS EasyVision / EasyAccess Release 10.1/10.2 Site numbers 542691, 105592, 519705, 100640, 541132, 530547, 76937, 105094, 505455, 85176, 105803, 105806, 505284, 13928, 105176, 505609, 536655, 86261, 105090, 101590, 105419, 84402, 505625, 104599, 505829, 532250, 105105, 103767, 532248, 541162, 85052, 532200, 20920024, 105257, 532654, 532642, 533323, 86050, 506259, 533223, 538795, 105106, 505267, 104946, 538798, 84026, 84033, 83937, 538801, 103513, 105374, 506328, 536253, 542386, 533622, 538484, 104551, 103066, 537982, 505674, 530752, 506046, 85173, 100592, 505623, 101168, 506700, 506367, 532390, 519811, 541133, 540768, 84083, 101378, 104982, 103096, 506265, 530448, 536658, 521136, 535317, 506000, 105026, 105067, 105043, 506505, 84896, 84873, 532946, 506461, 539156, 105604, 506122, 505973, 533999, 532691, 531852, 534508, 505388, 102155, 521761, 519977, 540771, 533268, 505001, 505183, 86345, 45053, 530661, 105021, 101356, 103220, 520416, 102594, 505065, 520458, 103340, 105931, 532583, 521516, 105765, 505796, 542077, 520442, 506228, 530805, 105599, 86457, 530553, 103715, 504825, 534766, 521200, 540249, 506001, 105517, 530555, 84967, 505897, 505898, 86198, 506161, 506226, 538802, 533720, 84866, 101033, 10381, 505427, 101419, 530518, 519965, 532368, 506707, 102076, 505044, 519629

Why it was recalled

Potential for measurements, lines, texts, etc to be stored incorrectly.

Root cause (FDA determination)

Other

Action the firm took

On 7/1/06 the firm issued a letter to consignees stating the problem and how to prevent the problem. The firm reports a software update will be issued no later than September 2006 to correct the problem.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2006-07-01
Posted by FDA: 2006-08-03
Terminated: 2008-05-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #46986. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.