FDA Medical Device Recalls (openFDA)
Philips Medical Systems Sales & Service Region No. America: OmniDiagnost System
- Recall number
- Z-0874-03
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Product
- OmniDiagnost System
- Status
- Terminated
- Initiated
- 2003-07-17
- Posted
- 2004-07-20
- Terminated
- 2005-01-12
- Reason
- Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID).
- Root cause
- Other
- Action
- On 7/17/03 the firm issued a letter dated June 12, 2003 to their customers advising that service personnel will visit the consignees and replace the buttons.
- Quantity
- 52
- Distribution
- The firm distributed devices to 81 hospitals and medical centers located throughout the U.S.
- Lot, serial or model codes
- OmniDiagnost User Interface PN 9896 000 59561, 9896 000 12381, 9896 000 58161; The firm utilizes a ''site number'' specific to each unit: 101599, 103055, 103058, 100520, 100873, 101152, 101154, 101676, 101962, 102164, 102582, 102977, 103050, 103051, 103052, 103055, 103058, 103218, 103219, 104012, 104577, 104858, 104934, 105324, 105394, 13124, 38351, 50428, 76596, 76944, 76948, 82655, 83871, 83958, 84441, 84850, 85163, 85165, 86113, 86303, 86326, 86339, 86340, 86485, 86486, 86549, 86965, 86977, 87164, X1707, X1747, 104857
- 510(k) numbers
- ["K982993"]
- PMA numbers
- not on file
- Product code
- not on file
- 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