MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer
FDA device recall Z-0661-2007 · posted 2007-03-29 · Terminated
Recall details
- Recalling firm
- Sonosite, Inc.
- Reason for recall
- Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db.
- Action taken
- 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
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 6 Devices
- Distribution
- Distribution to USA (Tennessee & Ohio), France, Korea, and Germany.
- Date initiated
- 2007-02-05
- Date posted
- 2007-03-29
- Date terminated
- 2007-06-01
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) (K053069) | Sonosite,Inc. | 2005-11-16 |
| SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) (K043559) | Sonosite,Inc. | 2005-01-12 |