FDA Medical Device Recalls (openFDA)
Philips Medical Systems Sales & Service Region No. America: Diagnost 97
- Recall number
- Z-1242-03
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Product
- Diagnost 97
- 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
- 38
- Distribution
- The firm distributed devices to 81 hospitals and medical centers located throughout the U.S.
- Lot, serial or model codes
- Diagnost 97 system code 708023, 70852, 70853, 70855, 70859. The firm utilizes a ''site number'' specific to each unit: 13608, 17605, 37995, 38897, 40940, 47166, 59633, 62936, 62937, 6935, 6981, 74057, 13709, 17436, 35481, 59497, 62885, 74056, 76345, 13951, 13971, 38500, 38530, 38657, 41372, 45013, 45014, 62988, 6993, X0668, X1069, X1207, 6852, 62504, 38023, 62666, 62667, 6853
- 510(k) numbers
- ["K912470"]
- 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