Recall Z-1160-2012 ยท FEM Accessories, Photographic, For Endoscope (Exclude Light Sources)
Olympus America Inc.
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
| Date | Mar 5, 2012 (initiated Oct 28, 2011) |
| Status | Terminated |
| Reason | Replacement wheels may break off from the base of the cart |
| 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 | 5 |
| Distribution | Nationwide Distribution including AL, CA, NY and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.