Recall Z-1763-2020 ยท GCJ Laparoscope, General & Plastic Surgery
Olympus Corporation of the Americas
Olympus Pleuravideoscope, Model LTF-240
| Date | Mar 23, 2020 |
| Status | Terminated |
| Reason | There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Correction notification letter dated 3/23/20 was sent to customers. Actions to be taken by the user: Our records indicate that your facility has purchased one or more of the above-referenced endoscopes. OLYMPUS requires that you take the following actions: a) Inspect your inventory of operation manuals for the referenced Olympus models and discard the existing ones. b) Exchange them with the updated, enclosed Operation Manuals having an updated system chart indicating compatible endoscope accessories. c) Notify related personnel at your institution that they should st |
| Quantity | 265 total |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013617 | LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS Olympus Optical Co., Ltd., Jan 30, 2002 |