FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with Multi Planar Reformat (MPR) Option
- Recall number
- Z-1353-06
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with Multi Planar Reformat (MPR) Option
- Status
- Terminated
- Initiated
- 2006-07-01
- Posted
- 2006-08-03
- Terminated
- 2008-05-21
- Reason
- Potential for measurements, lines, texts, etc to be stored incorrectly.
- 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
- 157 devices
- Distribution
- Nationwide.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K033088"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28