Reported Aug 25, 2021 · Ongoing
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and…
Hitachi Healthcare Americas Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hitachi Healthcare Americas Corporation · 1959 Summit Commerce Park · Twinsburg, OH · 44087-2371
Is this the product you have?
- Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
- Lot codes and dates
- Serial Numbers
165 of 165 codes
205048352050483620504837205048382050483920556338205563692055637020615320206153212063921720639218206392192063922320639224206392252063922620639230206652902069315420693155206931562069315720693158206931592069316020693161206E0051206E0058206E0059203R8980203R8981203R8986203R8987203R8988203R9022203R9023203R9031203R9032203R9033203R9034203R9035203R9036203R9037203R9038203R9041203R9042203R9047203R9048204J8480204J8481204J8482204J8483204J8484204Q3434204Q3435204S3741204S3742204S3746204S3747
- Serial Numbers
- Amount recalled
- 120 units
Where it was sold
- Nationwide
Why it was recalled
The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and before and after an interoperative procedure.
This product could cause temporary or reversible health problems — stop using it.
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