Recall Z-2654-2010 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Sonosite, Inc.
Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx ultrasound system. The LAP Transducer label is labeled in part: "MicroMaxx LAP...Manufactured for SonoSite, Inc., Bothell, WA 98021".
| Date | Oct 1, 2010 (initiated Nov 2, 2007) |
| Status | Terminated |
| Reason | Sterilization of the SonoSite LAP surgical Transducer with the Sterrad NX System may result in damage to the transducer. |
| Root cause | 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 al |
| Quantity | 16 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, U |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043559 | SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) Sonosite,Inc., Jan 12, 2005 |