Recall Z-1605-2018 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems Nederlands
MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
| Date | May 3, 2018 (initiated Mar 26, 2018) |
| Status | Terminated |
| Reason | The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, BU IGT Systems, sent an "URGENT- Field Safety Notice" letter dated 3/23/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to stop using the system and call your Philips representative if the following situations occurs: -the table height or tilt movement is not working. - you notice a cracking or snapping sound during system operation. - you experience a blockade in the table height or tilt movement during system movements. -the system is having an unexpected collision or the system had an unexpected collision in |
| Quantity | 37 |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Farce Islands, Finland, France, Germany, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Korea, Republic of, Latv |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023441 | PHILIPS MULTIDIAGNOST ELEVA Philips Medical Systems, Oct 30, 2002 |