FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose Diagnostic Radiography.
- Recall number
- Z-0905-2011
- Recalling firm
- Philips Healthcare Inc.
- Product
- BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose Diagnostic Radiography.
- Status
- Terminated
- Initiated
- 2011-01-17
- Posted
- 2011-03-04
- Terminated
- 2020-08-11
- Reason
- Affected systems were determined not to prevent run-on of a selected technique factor if the technique selector and the exposure control were activated simultaneously.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- A Customer Information BuckyDiagnost Diagnostic X-Ray System letter, dated January 6, 2011, was sent to customers. The letter identifies the affected product, the reason for the recall, actions that are to be taken by customers, and actions that are planned by the firm. Customers are advised to make sure that the desired exposure values are displayed and that they have released the technique button BEFORE they start the exposure by pressing the exposure switch whenever manually changing the exposure parameters and in order to avoid the problem. Philips will issue a Field Change Order (FCO) to resolve the issue by updating the system software free of charge. Philips will contact customers to implement the FCO. Further information or support concerning this issue can be obtained by contacting your local Philips representative. The Field Service Engineers began software implementation the week of March 21, 2011.
- Quantity
- 1810 units in the US
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- 704031 / 70408
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IZO
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- 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