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Terminated

MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer

FDA Recall Z-0661-2007 · Posted 2007-03-29

Recalling FirmSonosite, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2007-02-05
Date Terminated2007-06-01
Product Quantity6 Devices

Reason for Recall

Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db.

Firm Action

On 2/5/2007 firm sent by FED-Ex notification letters to firm representatives. Representatives began hand delivery of recall letter to consignees and retrieval of LAP transducer for return delivery to firm. The letter advised customers that the LAP transducer exceeded the limits specified for radio-frequency emissions. The firm also advised that exceeding the limit may cause the LAP transducer to interfere with surrounding equipment that may be susceptible to radiated emissions and cause surrounding equipment to not perform as expected.

Root Cause

Other

Distribution Pattern

Distribution to USA (Tennessee & Ohio), France, Korea, and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053069SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)Sonosite,Inc. · 2005-11-16K043559SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)Sonosite,Inc. · 2005-01-12

Official Source

View FDA Recall →

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

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