FDA Medical Device Recalls (openFDA)
Sonosite, Inc.: 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".
- Recall number
- Z-2655-2010
- Recalling firm
- 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".
- Status
- Terminated
- Initiated
- 2007-11-02
- Posted
- 2010-10-01
- Terminated
- 2010-10-05
- Reason
- Sterilization of the SonoSite SLT ultrasound 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 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K043559"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 3002087856
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28