Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.
Reported: March 7, 2018 Initiated: October 20, 2017 #Z-0816-2018
Product Description
Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.
Reason for Recall
The ultrasound probe may not have adequate protection against electrical shock hazards.
Details
- Recalling Firm
- Hitachi Medical Systems America Inc
- Units Affected
- 55
- Distribution
- Distributed in 21 states: AR, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NY, OK, OR, PA, SC, TX, VA, WA, WV.
- Location
- Twinsburg, OH
Frequently Asked Questions
What product was recalled? ▼
Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.. Recalled by Hitachi Medical Systems America Inc. Units affected: 55.
Why was this product recalled? ▼
The ultrasound probe may not have adequate protection against electrical shock hazards.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 7, 2018. Severity: Moderate. Recall number: Z-0816-2018.
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