Recall Z-0081-04 ยท FFK Lithotriptor, Electro-Hydraulic
Richard Wolf Medical Instrument Corp
Sonotrode Probe, a straight nephroscopy probe with a 3.5 mm diameter and 362 mm working length; an accessory to the Richard Wolf Model 2271 Ultrasound Generator Unit 2271; Richard Wolf Medical Instruments Corp., Vernon Hills, IL 60061
| Date | Jul 20, 2004 (initiated Oct 9, 2003) |
| Status | Terminated |
| Reason | The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device. |
| Root cause | Other |
| Action | Recalled from the hospitals by sales representative telephone calls on 10/9/03 and follow-up visits to retriev the recalled lot and replace the units with a new lot of sonotrodes. |
| Quantity | 10 probes |
| Distribution | Nebraska, Oregon, Minnesota and Illinois. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011065 | INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) Richard Wolf Medical Instruments Corp., May 9, 2001 |