Food, drugs, devices › Philips Medical Systems Nederlands
Device recall: MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography a
FDA enforcement event 79783 is a device recall by Philips Medical Systems Nederlands of Best, N/A, initiated 26 Mar 2018 and classified Class II, with 7 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 12 Jun 2020. Initiation: voluntary: firm initiated. Philips Medical Systems Nederlands has 8 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips Medical Systems Nederlands, Best, N/A, Netherlands.
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."
Distribution
"Worldwide Distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Farce Islands, Finland,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1603-2018 | MultiDim Eleva 708032 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. | 184 | Class II | Terminated | 9 May 2018 |
| Z-1604-2018 | 708033 URODiagnost 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. | 20 | Class II | Terminated | 9 May 2018 |
| Z-1605-2018 | 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. | 37 | Class II | Terminated | 9 May 2018 |
| Z-1606-2018 | Mutlidiagnost-Eleva with Flat Detector 708034 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. | 206 | Class II | Terminated | 9 May 2018 |
| Z-1607-2018 | Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 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. | 199 | Class II | Terminated | 9 May 2018 |
| Z-1608-2018 | MultiDiagnostic-Eleva with Flat Detector 708038 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. | 184 | Class II | Terminated | 9 May 2018 |
| Z-1609-2018 | MultiDiagnostic-Eleva with Flat Detector 708035 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. | 1 | Class II | Terminated | 9 May 2018 |
Context
Other enforcement events for Philips Medical Systems Nederlands
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 25 Mar 2019 | Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are i | Device | Class II | 1 |
| 19 Feb 2019 | Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura | Device | Class II | 2 |
| 21 Dec 2018 | Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System | Device | Class II | 64 |
| 3 Dec 2018 | Ingenia Elition S, Ingenia Elition X | Device | Class II | 1 |
| 30 Nov 2018 | Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 | Device | Class II | 1 |
| 1 May 2018 | OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028 | Device | Class II | 2 |
| 23 Jun 2016 | Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035 | Device | Class II | 1 |
All 8 events for Philips Medical Systems Nederlands
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Farce Islands, Finland,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 Jun 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.