Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1160-2012

Olympus Mobile Workstations (Endoscopy Carts), Models WM-DP1, WM-NP1 and WM-WP1 The mobile workstations are...

OLYMPUS Corporation of the Americas / initiated 2011-10-28 / Terminated / root cause: manufacturing process

Olympus America Inc. began a recall of 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... on . The reason FDA records is "Replacement wheels may break off from the base of the cart". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1160-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
OLYMPUS Corporation of the Americas
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
Product code
FEM Accessories, Photographic, For Endoscope (Exclude Light Sources)
Reason for recall
Replacement wheels may break off from the base of the cart
Root cause tag
manufacturing process
FDA root cause
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.
Product codes and lots
Models WM-DP1, WM-NP1 and WM-WP1 units with replacements wheels/castors