OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Reported: June 10, 2020 Initiated: April 23, 2020 #Z-2197-2020
Product Description
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Reason for Recall
A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 18
- Distribution
- Distribution US nationwide to states of: Texas, Ohio, New Mexico, California, Oklahoma, Michigan, Connecticut, North Carolina, Nebraska, and Pennsylvania; and Canada.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer. Recalled by Olympus Corporation of the Americas. Units affected: 18.
Why was this product recalled? ▼
A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 10, 2020. Severity: Moderate. Recall number: Z-2197-2020.
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