510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-2655-2010

SLT transducer is used on the SonoSite MicroMaxx ultrasound system. The SLT Transducer label is labeled in...

FUJIFILM SonoSite,Inc. / initiated 2007-11-02 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Sonosite, Inc. began a recall of SLT transducer is used on the SonoSite MicroMaxx ultrasound system. The SLT Transducer label is labeled in part: " MicroMaxx SLT...Manufactured for SonoSite... on . The reason FDA records is "Sterilization of the SonoSite SLT ultrasound surgical transducer with the Sterrad NX System may result in damage to the transducer". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2655-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
FUJIFILM SonoSite,Inc.
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".
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall
Sterilization of the SonoSite SLT ultrasound surgical transducer with the Sterrad NX System may result in damage to the transducer.
Root cause tag
manufacturing process
FDA 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 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 [email protected] 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.
Product codes and lots
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.