Shockpulse Lithotripsy System
- Recalling firm
- Olympus (NZ) Ltd
- Product
- ShockPulse Lithotripsy System. [Device]. Model: ShockPulse-SE Lithotripsy System – Reusable Probes and ShockPulse Lithotripsy Generator. Affected: Serial number - CG6069
- Reason
- The manufacturer has identified through an internal investigation that specific serial numbers of ShockPulse generators may have a mis-wired component. This condition does not impact the intended functionality of the device; however, the miswiring may introduce additional electrical noise on the power supply output. The presence of noise on the ultrasonic input circuit is not compliant with applicable electromagnetic compatibility (EMC) standards and may adversely affect the overall reliability of the system.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-01-05
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/29415478-8c73-4041-aff5-c89d73a107ab