The Recall Desk

FDA (Devices) recall action 79783

Philips Medical Systems Nederlands recalled 7 products on 2018-05-09

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2018-05-09
Critical
0
Units
831

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–7 of 7

  • SevereFDA (Devices)··2018-05-09

    Philips MultiDim Eleva Imaging System Recalled for Uncontrolled Table Rotation

    Philips is recalling 184 MultiDim Eleva imaging systems because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.

    Product
    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.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2018-05-09

    Philips MultiDiagnost Eleva Imaging System Recalled for Uncontrolled Table Rotation

    Philips is recalling 37 MultiDiagnost Eleva imaging systems because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.

    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.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2018-05-09

    Philips MD-Eleva Medical Imaging System Recalled for Tilt Actuator Failure

    Philips is recalling 199 MD-Eleva imaging systems because a tilt actuator may break, causing the table to rotate uncontrollably at high speed.

    Product
    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.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2018-05-09

    Philips MD-Eleva Imaging System Recalled for Uncontrolled Table Rotation

    Philips is recalling 206 MD-Eleva imaging systems because the tilt actuator fixation may break, causing the table to rotate uncontrollably at high speed.

    Product
    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.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2018-05-09

    Philips MultiDiagnostic-Eleva Imaging System Recalled Due to Uncontrolled Table Rotation

    Philips is recalling the MultiDiagnostic-Eleva imaging system because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.

    Product
    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.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2018-05-09

    Philips MultiDiagnostic-Eleva Recalled Due to Uncontrolled Table Rotation Hazard

    Philips Medical Systems is recalling 184 MultiDiagnostic-Eleva systems because a broken actuator fixation can cause the table to rotate uncontrollably at high speed.

    Product
    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.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2018-05-09

    Philips URODiagnost Imaging System Recalled Due to Uncontrolled Table Rotation

    Philips Medical Systems is recalling 20 URODiagnost imaging systems because the tilt actuator fixation may break, causing the table to rotate uncontrollably at high speed.

    Product
    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.
    Category
    Distribution
    0 states