Model L43K Intraoperative Probe-For the diagnostic recall
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
Why was Model L43K Intraoperative Probe-For the diagnostic 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 20504835, 20504836, 20504837, 20504838, 20504839, 20556338, 20556369, 20556370, 20615320, 20615321, 20639217, 20639218, 20639219, 20639223, 20639224, 20639225, 20639226, 20639230, 20665290, 20693154, 20693155, 20693156, 20693157, 20693158, 20693159, 20693160, 20693161, 206E0051, 206E0058, 206E0059, 203R8980, 203R8981, 203R8986, 203R8987, 203R8988, 203R9022, 203R9023, 203R9031, 203R9032, 203R9033, 203R9034, 203R9035, 203R9036, 203R9037, 203R9038, 203R9041, 203R9042, 203R9047, 203R9048, 204J8480, 204J8481, 204J8482, 204J8483, 204J8484, 204Q3434, 204Q3435, 204S3741, 204S3742, 204S3746, 204S3747, 204S3755, 204S3757, 204S3758, 204S3759, 204S3760, 204S3773, 204U7420, 205B5697, 205B5703, 205B5713, 205F1090, 205F1091, 205F1092, 205F1093, 205F1095, 205F1097, 205F1109, 205F1110, 205F1119, 205Q9088, 205Q9089, 205Q9090, 205Q9091, 205Q9099, 206G6141, 206G6149, 206G6150, 206G6151, 206G6152, 206G6153, 206G6154, 206G6155, 206G6156, 206G6157, 206G6158, 206G6164, 206G6166, G3002072, G3002073, G3002074, G3002076, G3002077, G3002078, G3002079, G3002080, G3002081, G3002082, G3002083, G3002084, G3002086, G3002087, G3002088, G3002089, G3002090, G3002091, G3009910, G3009911, G3009972, G3009973, G3009974, G3020256, G3020257, G3020265, G3020270, G3020271, G3020276, G3020282, G3020283, G3020284, G3020285, G3020286, G3020287, G3020288, G3020289, G3020290, G3020291, G3020292, G3020293, G3020294, G3042776, G3054934, G3054935, G3056539, G3056540, G3056541, G3056542, G3056543, G3056544, G3056545, G3056546, G3056547, G3056548, G3056549, G3056550, G3056551, G3056552, G3056555, G3072337, G3072338, G3072339, G3072340, G3072341, G3072364, G3073380, G3079843
- Product
- Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
- Recalling firm
- Hitachi Healthcare Americas Corporation
- Quantity
- 120 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall date
- August 25, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)