Recall Z-1514-2015 ยท KQM Camera, Surgical And Accessories
Sony Latin America
Sony Medical Monitor LMD-1951MD 19 inch
| Date | Apr 23, 2015 (initiated Mar 5, 2015) |
| Status | Terminated |
| Reason | Monitor has either not turned on or has lost image during clinical use. |
| Root cause | Nonconforming Material/Component |
| Action | SOLA sent an URGENT MEDICAL DEVICE FIELD ACTION dated March 2, 2015, to all affected customers. Within that notification SOLA requests that you send the customer letter included in Attachment 1 of this notification to all customers who have purchased the affected monitors from you. The letter instructs customers who already possess an AC adapter for each of their affected monitors to only use the AC adaptor when the monitors are in use. If you have units in inventory that can be provided with an AC adapter, we will provide under separate cover kits that contain: 1) a sticker warning and 2 |
| Quantity | 4,764 units |
| Distribution | Worldwide Distribution - US Distribution to the states of : FL and NC., and to the countries of : Ecuador, Costa Rica, Brazil, Nicaragua, Venezuela, Peru, Colombia, Dominican Republic, and South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.