Recall Z-1983-2019 ยท FEM Accessories, Photographic, For Endoscope (Exclude Light Sources)
Olympus Corporation of the Americas
Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664
| Date | Jun 10, 2019 |
| Status | Terminated |
| Reason | WM-NP/DP2 workstations could become unstable and may fall over if the control panel arm is mounted with a video monitor weighing more than 19.8 pounds. |
| Root cause | Under Investigation by firm |
| Action | On June 24, 2019, the firm initiated customer notifications in the form of Urgent Medical Device Corrective Action letters. The firm notified users that the following conditions could lead to the workstation becoming unstable and falling over: 1. A monitor weighing more than 19.8 lbs. is attached to the MAJ-1664. 2. The Nurse Control Arm (MAJ-1664) and LCD Monitor Arm (MAJ-1641) are mounted on the WM-NP2/DP2 and are extended in the same direction, which is an unfavorable position in the same direction (e.g. towards the left or right of the workstation). 3. Total weight of the equipment a |
| Distribution | Nationwide domestic distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.