Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx ultrasound system. The LAP Transdu

FDA device recall Z-2654-2010 · posted 2010-10-01 · Terminated

Recall details

Recalling firm

Sonosite, Inc.

Reason for recall

Sterilization of the SonoSite LAP surgical Transducer with the Sterrad NX System may result in damage to the transducer.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

IYN

Quantity affected

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, G

Date initiated

2007-11-02

Date posted

2010-10-01

Date terminated

2010-10-05

Location

Bothell, WA

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