Recall Z-2300-2018 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Medical Systems Nederlands
OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
| Date | Jun 27, 2018 (initiated May 1, 2018) |
| Status | Terminated |
| Reason | The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating movement can not be stopped by the user. This could potentially lead to the patient falling off the table. There is a risk of injury for the patient, user, or bystander. |
| Root cause | Device Design |
| Action | On May 17, 2018, the firm issued Urgent Medical Device Correction letters to affected consignees. Customers were advised of the product issue. Customers were instructed to do the following: Stop using the system and call your Philips representative if any of the following situations occurs: . the table height or tilt movement is not working. . you notice a cracking sound or snapping sound different than the normal sound during height or tilt movement. . you experience a blockade in the table height or tilt movement during system movements. . the system is having an unexpected collision or t |
| Quantity | 508 |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032046 | PHILLIPS OMNIDIAGNOST ELEVA Philips Medical Systems, Inc., Jul 17, 2003 |