Date Initiated by Firm |
June 10, 2019 |
Create Date |
July 17, 2019 |
Recall Status1 |
Terminated 3 on July 10, 2020 |
Recall Number |
Z-1983-2019 |
Recall Event ID |
83171 |
Product Classification |
Accessories, photographic, for endoscope (exclude light sources) - Product Code FEM
|
Product |
Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664 |
Code Information |
All serial numbers |
Recalling Firm/ Manufacturer |
Olympus Corporation of the Americas 3500 Corporate Pkwy PO Box 610 Center Valley PA 18034-0610
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For Additional Information Contact |
Technical Assistance Center 800-848-9024
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Manufacturer 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.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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