| Class 2 Device Recall SLT Ultrasound Surgical Transducer | |
Date Initiated by Firm | November 02, 2007 |
Date Posted | October 01, 2010 |
Recall Status1 |
Terminated 3 on October 05, 2010 |
Recall Number | Z-2655-2010 |
Recall Event ID |
49387 |
510(K)Number | K043559 |
Product Classification |
Ultrasound Surgical Transducer - Product Code IYN
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Product | SLT transducer is used on the SonoSite MicroMaxx ultrasound system. The SLT Transducer label is labeled in part: " MicroMaxx SLT...Manufactured for SonoSite, Inc., Bothell, WA 98021". |
Code Information |
38 units are identified with Serial numbers: 0361MW, 036MH5, 0365TR, 036MH3, 0360VT, 036MGZ, 03661X, 035TCZ, 037Y9N, 036MH1, 0365TN, 0360VW, 03661W, 035KXD, 037Y9M, 035KXC, 037Y84, 036MH6, 037Y9L, 0365TX, 03616X, 037Y8D, 037Y83, 0365TW, 035L1M, 036MH8, 035TXC, 0360TN, 0361MQ, 03616Z, 035NTF, 034RZG, 037YKG, 037YKH, 0361CG, 036MH9, 0365TT and 037YKM. |
Recalling Firm/ Manufacturer |
Sonosite, Inc. 21919 30th Dr Se Bothell WA 98021-3904
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For Additional Information Contact | 425-951-1330 |
Manufacturer Reason for Recall | Sterilization of the SonoSite SLT ultrasound surgical transducer with the Sterrad NX System may result in damage to the transducer. |
FDA Determined Cause 2 | Process control |
Action | On November 2, 2007, SonoSite sent out the Important Information Regarding Sterrad NX Incompatibility letter and the Technical Bulletin 005/07 Rev A to their consignees. The letter advises the consignees that SonoSite has recently found that sterilization of the SonoSite SLT and LAP surgical ultrasound transducers with the Sterrad NX system may result in damage to the transducer.
The Technical Bulletin 005/07 Rev B dated November 2, 2007 informs the consignees that the damage has been observed primarily on the circuit board in the transducer connector, and cable and laparoscope damage may also be occurring. All damages have occurred after processing using the Sterrad NX systems in its "Advanced" cycle and the potential damage from the use of "normal" cycle is being evaluated by the firm.
Consignees should call the Technical Support at 1-425-951-1330 or 1-877-657-8118 or e-mail to service@sonosite.com for any questions regarding the recall. |
Quantity in Commerce | 38 units |
Distribution | Devices were distributed to medical centers and hospitals in AR, CA, IN, KS, MA, MD, MI, NC, NE, NJ, NV, OH, SC, TN, TX, WI, Washington DC
and to FOREIGN COUNTRIES Australia, China, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Korea, Republic of, Libyan Arab Jamahiriya, Mexico, Spain, United Arab Emirates, United Kingdom, and United States. |
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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