Z-1983-2019Class II

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

Name: Z-1983-2019 Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664
Creator: Olympus Corporation of the Americas
Published: 2019-06-10
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2019-06-10 / Terminated

FDA source

Olympus Corporation of the Americas began a recall of Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664 on 2019-06-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1983-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-10
Posted: 2019-07-17
Terminated: 2020-07-10
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664
Product code: FEM Accessories, Photographic, For Endoscope (Exclude Light Sources)
Reason for recall: 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.
FDA 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 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
Distribution: Nationwide domestic distribution.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1983-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1983-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-17

Product code FEM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)