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Terminated

OminDiagnost Eleva

FDA Recall Z-0352-2009 · Posted 2009-09-24

Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeJAA
Date Initiated2008-12-10
Date Terminated2012-08-17
Product Quantity69 units

Reason for Recall

Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.

Firm Action

An Electronic Product Radiation Warning, dated October 2008, was sent to customers. The letter identified the problem and under what circumstances that it could occur; the actions that should be taken by the customer/user to prevent risks for patients or users; and the actions planned by Philips to correct the problem. Further information or support concerning the issue could be obtained by contacting Bob Pettis at 425-487-7469 or the Philips Call Center at 800-722-9377. Firm FCO tracking numbers 72200107, 72200108, 72200111, 72200112, 72200117, 72200118, 72200119, 72200122, 72200123, 72200124, 72200125, 72200129, 72200142, 7989980, 7080085, 70600034, 70600035, 72200132, 72200133, 72200137, 72200138, 72200140 and 72200141. C & R # 1217116-10/20/08-016C

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032046PHILLIPS OMNIDIAGNOST ELEVAPhilips Medical Systems, Inc. · 2003-07-17

Official Source

View FDA Recall →

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

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