FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: BuckyDiagnost. General Radiography and Tomography examination of patients in supine, seated, or standing positions.
- Recall number
- Z-0848-2010
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- BuckyDiagnost. General Radiography and Tomography examination of patients in supine, seated, or standing positions.
- Status
- Terminated
- Initiated
- 2010-01-21
- Posted
- 2010-03-23
- Terminated
- 2011-01-25
- Reason
- Device failed to display appropriate labels indicating Radiation Symbol along with the required wording.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Urgent - Field Safety Notice letters, dated January 20 & 21, 2010, were sent to customers. The letter identified the affected products, gave a description of the problem & the hazard involved, stated how to identify affected products, actions to be taken by the customer or user, and actions planned by the firm. Customers are to make sure that the relevant safety precautions are observed and check their operators console (EEC) if the labeling is present as shown in the drawing. If the labeling is missing, a Philips rep should be contacted. For further information or support concerning the issue, a Philips rep should be contacted at 800-722-9377.
- Quantity
- 16 units
- Distribution
- Devices were distributed through out the US in the following states: AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, WI, and WY.
- Lot, serial or model codes
- Site Numbers: 545896, 17673, 62929, 102578, 104781, 250137, 250294, 505841, 538513, 539863, 542610, 545089, 548438, 557949, 43717870, and 44329671.
- 510(k) numbers
- ["K945278"]
- 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