—#173924

Product

Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664

FDA product code: FEM — Accessories, Photographic, For Endoscope (Exclude Light Sources)
Device class: Class 1
Medical specialty: Gastroenterology, Urology
Affected lot / code info: All serial numbers

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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 and accessories on the WM-NP/DP2 workstation shelves of less than 66.1lbs 4. When the workstation is stationary on an incline/decline and the brakes are engaged. The communication required customers take the following actions: 1. Review the updated Instructions for Use (Revision Issue 5) regarding the Control Panel Arm and ensure that any monitor placed on the Control Panel Arm does not exceed the maximum loading of 19.8 lbs. 2. If you are currently using a monitor that exceeds the updated maximum loading requirement with the Control Panel Arm, ensure the monitor is removed and replaced with a new monitor that does not exceed 19.8lbs. Please contact your local Olympus Representative for further support. 3. A self-fastening strap should always be used with the Control Panel Arm. Enclosed with the customer notification letter were self-fastening strap(s). Customers were asked to see the updated IFU and apply the supplied self-fastening strap according to the instructions. 4. Inspect your inventory of Instructions for Use (IFU) for the Control Panel Arm and discard any existing IFUs. 5. Olympus recommends that the Control Panel Arm is placed within its storage location and to avoid the four conditions stated within this Field Safety Notice when the WM-NP2/DP2 is transported. 6. Ensure you train your personnel on the updated Instructions for Use for

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

Distribution pattern: Nationwide domestic distribution.

Timeline

Recall initiated: 2019-06-10
Terminated: 2020-07-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173924. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.