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Terminated

Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System The Diagnost is a multifunctional, universal X~ray system with remote controlled facilities. Routine examinations that can be performed with the Diagnost include: Gastro-Intestinal examination, Urograpy, Bronchography, Arthrography, Hysterography, Myelography, Lymphography, Skeletal radiography, Tomography and Venography/phlebography. Special procedures that require subtracted and non subtracted digital imaging include: Angiography, Peripheral angiography (bolus chasing) and Vascular and non~vascular interventional procedures

FDA Recall Z-2765-2011 · Posted 2011-07-08

Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeJAA
Date Initiated2011-04-18
Date Terminated2013-02-15
Product Quantity52 units

Reason for Recall

Updated Instructions For Use: During an examination where the patient is positioned on a -rotatable- chair with knees pointed to the rear of the system, the patients lower legs or ankles may be injured/broken

Firm Action

Philips Healthcare notified accounts by letter on April 18, 2011. The letter advised users of the problem and provided updated instructions for proper placement of the patient during the examination. An Updated Instruction For Use was provided. For further information and support customers were instructed to contact the Philips representative.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K912470PHILIPS DIAGNOST 96Philips Medical Systems, Inc. · 1991-08-07

Official Source

View FDA Recall →

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

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