Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1353-06

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

Philips North America LLC / initiated 2006-07-01 / Terminated

Philips Medical Systems North America Co. Phillips began a recall of Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with Multi Planar Reformat (MPR) Option on . The reason FDA records is "Potential for measurements, lines, texts, etc to be stored incorrectly". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1353-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with Multi Planar Reformat (MPR) Option
Product code
LLZ System, Image Processing, Radiological
Reason for recall
Potential for measurements, lines, texts, etc to be stored incorrectly.
FDA root cause
Other
Action
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.
Quantity in commerce
157 devices
Distribution
Nationwide.
Product codes and lots
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