Recall Z-0683-2016 ยท IYE Accelerator, Linear, Medical
Iba Dosimetry Gmbh
IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
| Date | Jan 21, 2016 (initiated Dec 10, 2015) |
| Status | Terminated |
| Reason | When the electric lift table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner. |
| Root cause | Component design/selection |
| Action | The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email on 12/10/2015 then followed by 12/17/2015 sent by Fed Ex. The firm requested the mains power be disconnected after setting up the table and BP. Replacement part and instructions will follow. |
| Distribution | Nationwide and International: Algeria, Angola, Arab Republic of Egypt, Austria, Belarus, Belgium, Bulgaria, Bosnia and Herzegovina, Croatia, Czech Republic, Denmark, Ethiopia, France, Germany, Ghana, Greece, Hungary, Iraq, Ireland, Islamic Republic Iran, Italy, Kazakhstan, Kenya, Kingdom of Saudi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945321 | WELLHOFER WP700 V. 3.2 Medical Physics Instrumentation, Inc., Jul 12, 1995 |