Recalls / —

—#123097

Product

Easy Diagnost Eleva Universal Fluoroscopic applications

FDA product code

KPR — System, X-Ray, Stationary

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K031535

Affected lot / code info

706050, 706083, 706088

Why it was recalled

The delivered application software was an outdated version to the model of equipment.

Root cause (FDA determination)

Software design

Action the firm took

Philips Medical Systems sent an Urgent - Field Safety Notice dated October 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cusromers were informed that the delivered application software was an outdated version to the model of their expipment and that a Philips Field Engineer will be implementing an upgrade of the application software. Customers were instructed to review the information contained in the letter with all memebers of their staff who need to be aware of its contents. Customers with questions were instructed to contact their Philips representataive: Technical Support Line 1-800-722-9377. For questions regarding this recall call 1-800-722-9377.

Recalling firm

Firm

Philips Medical Systems, Inc.

Address

3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern

Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.

Timeline

Recall initiated

2013-10-30

Posted by FDA

2013-12-02

Terminated

2017-01-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #123097. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.