Hitachi Healthcare Americas Corporation Recall 88367
Description: Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
Hitachi Healthcare Americas Corporation Recall 88367 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2308-2021 |
| Event ID | 88367 |
| Event Description | Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| Quantity | 120 units |
| Recall Reason | 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. |
| Device Classification | 20210825 |
| Device Code Info | 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 |
| Center Classification Date | 20210816 |
| Recall Initiation Date | 20210630 |
| Recalling Firm | Hitachi Healthcare Americas Corporation |
| Initial Notification | Letter |
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