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Terminated

Easy Diagnost Eleva Universal Fluoroscopic applications

FDA Recall Z-0431-2014 · Posted 2013-12-02

Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeKPR
Date Initiated2013-10-30
Date Terminated2017-01-09
Product Quantity19 devices

Reason for Recall

The delivered application software was an outdated version to the model of equipment.

Firm Action

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 Cusromers were informed that the delivered application software was an outdated version to the model of their expipment and that a Philips Field Engineer will be implementing an upgrade of the application software.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.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031535PHILIPS EASYDIAGNOST ELEVAPhilips Medical Systems North America Co. · 2003-06-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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