FDA Medical Device Recalls (openFDA)
Philips Healthcare: Philips Healthcare DuraDiagnost stationary X-ray system
- Recall number
- Z-1696-2016
- Recalling firm
- Philips Healthcare
- Product
- Philips Healthcare DuraDiagnost stationary X-ray system
- Status
- Terminated
- Initiated
- 2015-11-10
- Posted
- 2016-06-03
- Terminated
- 2017-05-03
- Reason
- The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Philips Healthcare plans to correct the defect at no cost to customers by implementing a field correction involving the installation of new software. 1. You will contact customers and initiate a software update to correct the defect. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call 1-800- 722-9377.
- Quantity
- 5
- Distribution
- USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.
- Lot, serial or model codes
- software version - 4.0.2, 4.0.3, 4.0.4 into 4.0.5
- 510(k) numbers
- ["K141381"]
- PMA numbers
- not on file
- Product code
- KPR
- 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