SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer... SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021". The TEE/8-3 MHz Transducer is designed for 2D, M Mode, color Doppler, pulse wave (PW) Doppler and continuous wave (CW) Doppler by applying ultrasound energy through the esophagus or stomach of the patient into the heart. The TEE transducer is intended to be used on adults only. Backscattered ultrasound energy from the patient's heart is used to form images of the heart to detect abnormalities in structure or motion, to evaluate the velocity of blood flowing within the heart, and to obtain a color depiction of the velocities of blood flowing in the heart.
Recall
- Recall Number
- Z-2191-2010
- Event Number
- 49374
- Firm
- Sonosite, Inc.
- FEI Number
- 3002087856
- Product Code
- IYO
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 8, 2008
- Posted
- August 9, 2010
- Terminated
- August 24, 2011
- Address
- 21919 30th Dr Se, Bothell, WA, 98021-3904
Description
SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer... SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021". The TEE/8-3 MHz Transducer is designed for 2D, M Mode, color Doppler, pulse wave (PW) Doppler and continuous wave (CW) Doppler by applying ultrasound energy through the esophagus or stomach of the patient into the heart. The TEE transducer is intended to be used on adults only. Backscattered ultrasound energy from the patient's heart is used to form images of the heart to detect abnormalities in structure or motion, to evaluate the velocity of blood flowing within the heart, and to obtain a color depiction of the velocities of blood flowing in the heart.
The TEE transesophageal transducer, when connected to a SonoSite M-Turbo Ultrasound System, may exhibit erratic operation of the Scanplane Orientation Indicator on the system display. The indicator may move erratically and not accurately represent the orientation of the TEE transducer array.
On August 21, 2008, SonoSite began calling 15 consignees who have purchased the TEE/8-3 MHz Transducer and an M-Turbo 1.1 system. The firm provided instruction to discontinue use the system to 11 consignees and left voice messages to the remaining four consignees. On August 21, 2008, SonoSite sent out the URGENT-MEDICAL DEVICE CORRECTION letter and the Urgent Field Safety Notice to all affected consignees in the US and in foreign countries. The URGENT-MEDICAL DEVICE CORRECTION letter describes the recall product as TEE/8-5 MHz Transducer, SonoSite Part Numbers P05183 and P06841. The letter informed the consignees that the TEE transesophageal transducers may exhibit erratic operation of the Scanplane Orientation Indicator on the system display when it connected to the SonoSite M-Turbo Ultrasound System. The letter instructs consignees to discontinue use of the TEE/8-3MHz Transducer with the M-Turbo (or Micromaxx system) immediately, while the firm is working to create a software solution to resolve the issue and offers customers a software upgrade within 6-8 weeks. The consignees are also advised to forward the recall notice to others who need to be aware of the issue or where the potentially affected devices have been distributed. Customers should call the Technical Support at 1-1-425-951-1330 or 1-877-657-8118 from Monday to Friday, 6 am-5 pm PST or e-mail to [email protected] for any questions regarding the recall.
Worldwide distribution: USA and countries including Argentina, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Finland, France, Germany, India, Iran, Ireland, Israel, Italy, Korea, Netherlands, New Zealand, Poland, Slovenia, South Africa, Spain, Switzerland, and Thailand.
357 units