FDA Device recall Z-1494-2026
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model…
- FDA Device
- Class II
- ongoing
- Published 2026-03-11
On 2026-03-11 the FDA classified a Class II recall of Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model… by Olympus, citing mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electrom….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1494-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-08 |
| Published | 2026-03-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Olympus |
| Distribution | n/a |
Product
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system.
Reason
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.
Identifiers
| code_info | Model/Catalog Number: SPL-SR, contains generator SPL-G; UDI: SPL-SR 00821925043824, SPL-G 00821925044203; Serial Numbe…Model/Catalog Number: SPL-SR, contains generator SPL-G; UDI: SPL-SR 00821925043824, SPL-G 00821925044203; Serial Numbers: CG5026, CG5027, CG5028, CG5029, CG5030, CG5031, CG5032, CG5033, CG5034, CG5035, CG5036, CG5037, CG5039, CG5040, CG5041, CG5042, CG5043, CG5045, CG5046, CG5047, CG5048, CG5049, CG5050, CG5051, CG5052, CG5053, CG5054, CG5055, CG5056, CG5057, CG5058, CG5059, CG5060, CG5061, CG5062, CG5063, CG5065, CG5066, CG5067, CG6037, CG6061, CG6069, CG6070, CG6071, CG6088, CG6094, CG6095, CG6096, CG6097, CG6098, CG6099, CG7000, CG7001, CG7002, CG7003; |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1494-2026%22
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