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Terminated

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

FDA Recall Z-0081-04 · Posted 2004-07-20

Recalling FirmRichard Wolf Medical Instrument Corp
Recall StatusTerminated
Product CodeFFK
Date Initiated2003-10-09
Date Terminated2004-02-10
Product Quantity10 probes

Reason for Recall

The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device.

Firm 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.

Root Cause

Other

Distribution Pattern

Nebraska, Oregon, Minnesota and Illinois.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011065INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)Richard Wolf Medical Instruments Corp. · 2001-05-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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