Date Initiated by Firm | February 05, 2007 |
Date Posted | March 29, 2007 |
Recall Status1 |
Terminated 3 on June 01, 2007 |
Recall Number | Z-0661-2007 |
Recall Event ID |
37452 |
510(K)Number | K043559 K053069 |
Product Classification |
Laparoscopic Ultrasound Transducer - Product Code IYN
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Product | MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer |
Code Information |
Serial Numbers: 037XT6, 0379P5, 037WMJ, 0379P1, 0379P2, 0379P0 Part Number: P05507-10 |
Recalling Firm/ Manufacturer |
Sonosite, Inc. 21919 30th Dr Se Bothell WA 98021-3904
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For Additional Information Contact | Daina L. Graham 425-951-1275 |
Manufacturer Reason for Recall | Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db. |
FDA Determined Cause 2 | Other |
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. |
Quantity in Commerce | 6 Devices |
Distribution | Distribution to USA (Tennessee & Ohio), France, Korea, and Germany. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = IYN
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