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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88367

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 30, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Hitachi Healthcare Americas Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures

Z-2308-2021
Recall number
Z-2308-2021
Initiated
June 30, 2021
Classification
Class II
Status
Ongoing
Quantity
120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.