Recalls / —

—#88886

Product

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

FDA product code

KPR — System, X-Ray, Stationary

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K945278

Affected lot / code info

Site Numbers:  545896, 17673, 62929, 102578, 104781, 250137, 250294, 505841, 538513, 539863, 542610, 545089, 548438, 557949, 43717870, and 44329671.

Why it was recalled

Device failed to display appropriate labels indicating Radiation Symbol along with the required wording.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm

Philips Medical Systems North America Co. Phillips

Address

22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2010-01-21

Posted by FDA

2010-03-23

Terminated

2011-01-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #88886. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.