Recall Z-1605-2018
Philips Medical Systems Nederlands · initiated March 26, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: System Serial # 18 42 46 41 36 35 37 47 27 43 10 5 24 29 34 49 26 13 15 25 50 12 17 48 32 30 31 14 40 19 9 16 45 8 4 21 11
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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 the past 2 months. - you have used a CPR stand that obstructed the system, or - you notice any (other) unusual system behavior beyond the normal use of the system. The customers should also avoid collisions with the table and base stand of the system by ensuring that no obstacles are placed around the system. In addition, ensure that all staff with access to the affected systems are informed of the content of this Field Safety Notice. The firm stated: -All possibly affected products in the field will be corrected by means of a field change order free of charge. -A firm representative will replace affected material on the upper and lower tilt actuator in the affected systems. -You will be contacted by our local Philips representative to schedule this corrective action. -This action will start effective April 2018. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722- 9377, 8am to 8pm (EST) Monday thru Friday.
Details
- Recall number
- Z-1605-2018
- Initiated
- March 26, 2018
- Posted by FDA
- May 3, 2018
- Terminated
- June 12, 2020
- Product code
- IZI – System, X-Ray, Angiographic
- 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, Latvia, Lebanon, Luxembourg, Malaysia, Martinique Mexico, Netherlands, New Zealand, Norway, Oman…
- Recalling firm
- Philips Medical Systems Nederlands, Best
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1603-2018 Class II | MultiDim Eleva 708032 As a multifunctional universal imaging application system, General…The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will… | 03/26/2018Terminated |
| Z-1604-2018 Class II | 708033 URODiagnost As a multifunctional universal imaging application system, General…The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will… | 03/26/2018Terminated |
| Z-1606-2018 Class II | Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging…The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will… | 03/26/2018Terminated |
| Z-1607-2018 Class II | Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a…The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will… | 03/26/2018Terminated |
| Z-1608-2018 Class II | MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging…The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will… | 03/26/2018Terminated |
| Z-1609-2018 Class II | MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging…The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will… | 03/26/2018Terminated |