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Terminated

Philips Multi Diagnost Eleva with FlatDetector

FDA Recall Z-1045-2015 · Posted 2015-02-26

Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeIZI
Date Initiated2013-10-14
Date Terminated2017-01-23
Product Quantity238

Reason for Recall

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.

Firm Action

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.

Root Cause

Radiation Control for Health and Safety Act

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050151MULTIDIAGNOST ELEVAPhilips Medical Systems North America, Inc. · 2005-02-09

Official Source

View FDA Recall →

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

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