Z-2765-2011

Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System The Diagnost is a multifunctional...

Name: Z-2765-2011 Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System The Diagnost is a multifunctional...
Creator: Philips Healthcare Inc.
Published: 2011-04-18
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-04-18 / Terminated / root cause: design

FDA source

Philips Healthcare Inc. began a recall of Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System The Diagnost is a multifunctional, universal X~ray system with remote controlled... on 2011-04-18. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2765-2011
Status: Terminated
Initiated: 2011-04-18
Posted: 2011-07-08
Terminated: 2013-02-15
Recalling firm: Philips North America LLC
Product: 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
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 52 units
Distribution: Nationwide Distribution
Product codes and lots: All serial numbers

Product code JAA

K912470Class IIPhilips Diagnost 96Philips Medical Systems, Inc. / cleared 1991-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)