Recall Z-2197-2020 ยท FEO Lithotriptor, Ultrasonic
Olympus Corporation of the Americas
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
| Date | Apr 23, 2020 |
| Status | Terminated |
| Reason | A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization. |
| Root cause | Component design/selection |
| Action | Olympus sent a Medical Device Field Removal Action letter, dated April 23, 2020, to all ShockPulse Transducer (Model SPL-T) customers with the affected serial numbers. The letter states that the transducer was manufactured with non-conforming material and could become warped during sterilization. They explained that the serial number of the transducers is found etched on the back of the device. The firm asked that the customers determine whether they have any of the affected product in stock. If customers have any of the affected product , they were instructed to quarantine the product. and co |
| Quantity | 18 |
| Distribution | Distribution US nationwide to states of: Texas, Ohio, New Mexico, California, Oklahoma, Michigan, Connecticut, North Carolina, Nebraska, and Pennsylvania; and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND II Cybersonics, Inc., Nov 13, 2014 |