TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
FDA device recall Z-0557-2024 · posted 2023-12-14 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- EOQ
- Quantity affected
- 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 Aus
- Date initiated
- 2023-09-28
- Date posted
- 2023-12-14
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT (K981543) | The Olympus Optical Co. | 1998-06-08 |