—#131730

Product

Philips Multi Diagnost Eleva II

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K023441
Affected lot / code info: Product Code: 708036

Why it was recalled

The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

Philips Healthcare Planned Action: 1. Software updates to SW R6.1.3 through Field Change Orders (FCOs) FCO70800140 and FCO70800142. 2. A customer notification letter which includes a statement that Philips Healthcare will without charge, remedy the defect or bring the product into compliance. 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Philips Healthcare will implement this CAP by September 1, 2015. For further questions please call (978) 687-1501.

Recalling firm

Firm: Philips Medical Systems, Inc.
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Worldwide Distribution - USA ( nationwide ) to the states of : AR, AZ, CA, CO, DE, FL, GA, HI, IL, IA, KY, KS, LA, MI, MO, MS, NC, NY, OH, PA, TN, TX, VA, VT, WA, WY and WV., and the countries of Austria, Australia, Colombia, Germany, Switzerland, Turkey, Ireland, Dubia and United Kingdom.

Timeline

Recall initiated: 2013-10-14
Posted by FDA: 2015-02-26
Terminated: 2017-01-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131730. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.