Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for pr
FDA device recall Z-1009-2024 · posted 2024-02-07 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis.
- Action taken
- On January 16, 2024, the firm notified customers of the issue via URGENT MEDICAL DEVICE FIELD CORRECTIVE ACTION letters. Customers were instructed to immediately assess all MAJ-2318 at their facility to check the model and lot number. Customers were given detailed instructions on how to identify affected product, including for MAJ-2318 installed in the OER machine. Please contact your Olympus customer service representative at 1-800-848-9024, option 2 to obtain a Return Material Authorization to return any affected product. Customers who have further distributed product should notify downstream accounts at once. If you require assistance with identifying affected product, please contact the Olympus Technical Assistance Center at 1- 800-848-9024, option 1. If you have questions about this recall, please contact the recalling firm at (647) 999-3203 or by e-mail at Cynthia.Ow@Olympus.com.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FEB
- Quantity affected
- 877 MAJ-2318, 119 OER-Elite, 3 OER-MINI
- Distribution
- Domestic US distribution nationwide.
- Date initiated
- 2024-01-16
- Date posted
- 2024-02-07
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO (K103264) | Olympus Medical Systems Corporation | 2011-02-23 |