Recall Z-0557-2024 ยท EOQ Bronchoscope (Flexible Or Rigid)
Olympus Corporation of the Americas
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
| Date | Dec 14, 2023 (initiated Sep 28, 2023) |
| Status | Open, Classified |
| Reason | Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device notification dated November 1, 2023 issued via UPS Ground. The notice advises customers to examine inventory for affected serial numbers and quarantine affected product. Contact Olympus Customer Solutions Team (1-800-848-9024, option 3) to arrange for for return. Olympus will inspect and repair if necessary. Customers are to forward notice to any facility affected product may have been transferred to. Olympus requests that you acknowledge receipt of this letter with Tara.Safi@Olympus.com. |
| Quantity | 75 |
| Distribution | Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA, GA, IL, IN, MA, MD, MI, NC, NJ, OH, TX, UT, VA, WA, WV & AP (Armed Forces Pacific) and the countries of OUS: EMEA, Japan and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981543 | OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT The Olympus Optical Co., Jun 8, 1998 |