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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus Mobile Workstations

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  Class 2 Device Recall Olympus Mobile Workstations see related information
Date Initiated by Firm October 28, 2011
Date Posted March 05, 2012
Recall Status1 Terminated 3 on January 14, 2014
Recall Number Z-1160-2012
Recall Event ID 60285
Product Classification Accessories, photographic, for endoscope (exclude light sources) - Product Code FEM
Product Olympus Mobile Workstations (Endoscopy Carts), Models WM-DP1, WM-NP1 and WM-WP1

The mobile workstations are intended for use in medical facilities under the direction of a trained physician, and has been designed to be used with a range of Olympus equipment to facilitate GI endoscopy, endoscopic ultrasound, respiratory and surgical endoscopic
Code Information Models WM-DP1, WM-NP1 and WM-WP1 units with replacements wheels/castors
Recalling Firm/
Manufacturer		 Olympus America Inc.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley PA 18034-0610
For Additional Information Contact Customer Support
484-896-5688
Manufacturer Reason
for Recall		 Replacement wheels may break off from the base of the cart
FDA Determined
Cause 2		 Equipment maintenance
Action OLYMPUS sent an Urgent - Device Correction letter dated October 28, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. OLYMPUS required customers indicate on the attached questionnaire the contact information for their facility so that they can schedule a convenient time for an Olympus Field Service Representative to visit. Service personnel would inspect, and replace, as necessary any user installed casters on the WM-P1 cart. For questions regarding this recall call (483) 896-5688.
Quantity in Commerce 5
Distribution Nationwide Distribution including AL, CA, NY and WV.
Total Product Life Cycle TPLC Device Report
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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