BuckyDiagnost. General Radiography and Tomography examination of patients in supine, seated, or standing positions.
FDA device recall Z-0848-2010 · posted 2010-03-23 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Device failed to display appropriate labels indicating Radiation Symbol along with the required wording.
- Action taken
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 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,
- Date initiated
- 2010-01-21
- Date posted
- 2010-03-23
- Date terminated
- 2011-01-25
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS BUCKY DIAGNOST FAMILY (K945278) | Philips Medical Systems North America, Inc. | 1994-12-14 |