Z-0848-2010

BuckyDiagnost. General Radiography and Tomography examination of patients in supine, seated, or standing...

Name: Z-0848-2010 BuckyDiagnost. General Radiography and Tomography examination of patients in supine, seated, or standing...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2010-01-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-01-21 / Terminated / root cause: labeling and UDI

FDA source

Philips Medical Systems North America Co. Phillips began a recall of BuckyDiagnost. General Radiography and Tomography examination of patients in supine, seated, or standing positions on 2010-01-21. The reason FDA records is "Device failed to display appropriate labels indicating Radiation Symbol along with the required wording". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0848-2010
Status: Terminated
Initiated: 2010-01-21
Posted: 2010-03-23
Terminated: 2011-01-25
Recalling firm: Philips North America LLC
Product: BuckyDiagnost. General Radiography and Tomography examination of patients in supine, seated, or standing positions.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Device failed to display appropriate labels indicating Radiation Symbol along with the required wording.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Site Numbers: 545896, 17673, 62929, 102578, 104781, 250137, 250294, 505841, 538513, 539863, 542610, 545089, 548438, 557949, 43717870, and 44329671.

Product code KPR

K945278Class IIPhilips Bucky Diagnost FamilyPhilips Medical Systems North America, Inc. / cleared 1994-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)