Recall Z-2765-2011 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Healthcare Inc.
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/phlebo
| Date | Jul 8, 2011 (initiated Apr 18, 2011) |
| Status | Terminated |
| Reason | 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 | 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 | 52 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912470 | PHILIPS DIAGNOST 96 Philips Medical Systems, Inc., Aug 7, 1991 |