Single Use Mechanical Lithotriptor V
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Single Use Mechanical Lithotriptor V |
3ZK |
BML-V442QR-30 |
Issue
Olympus has identified an increase in complaints for BML-V442QR-30. The complaint data analysis found that distal tip tearing of the Mechanical Lithotriptor V had increased beginning with the production of lot 33k. Olympus has identified 296 complaints for the BML-V442QR-30 globally between June 1, 2021, through July 31, 2024. There were 169 reportable malfunctions, and there was one report of a serious injury in relation to this issue.
Recall start date: December 18, 2024
Additional information
Details
| Olympus Medical Systems Corp. |
| 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507 |
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