FDA Medical Device Recalls (openFDA)
Philips Medical Systems Sales & Service Region No. America: EasyDiagnost Eleva Part Number 989605071921
- Recall number
- Z-1306-04
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Product
- EasyDiagnost Eleva Part Number 989605071921
- Status
- Terminated
- Initiated
- 2004-06-08
- Posted
- 2004-08-04
- Terminated
- 2006-02-09
- Reason
- When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.
- Root cause
- Other
- Action
- The firm mailed letters via certified mail to their affected customers beginning on June 8, 2004. The letters instruct their customers to modify the default display on the ViewForum to exam/series date and time until a service representative can install the upgraded software R3.2.
- Quantity
- 46
- Distribution
- Philips Medical Systems North American Company distributes product to medical facilities nationwide.
- Lot, serial or model codes
- The firm uses site numbers instead of serial numbers. 103164, 105323, 505806, 500032, 105589, 105337, 506439, 505063, 505749, 505653, 505295, 105152, 505385, 505003, 506211, 504541, 505015, 504981, 504611, 104179, 505754, 505671, 505104, 103539, 102551, 505069, 102549, 504962, 104812, 504743, 105777, 103515, 103522, 103523, 103588, 504966, 504882, 505056, 504879, 105921, 505798, 105640, 105776, 506199, 504804, 504803.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KPR
- 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