Hitachi L43K intraoperative probe recall: screw cover may detach during sterilization

Plain-English summary

Hitachi Healthcare Americas Corporation is recalling approximately 120 Model L43K intraoperative probes used for diagnostic ultrasound evaluation during surgical procedures. The screw cover at the probe tip may fall off after cleaning, sterilization, or disinfection.

If the cover detaches, it could compromise the sterility of the surgical field during intraoperative use and potentially affect the probe's functionality during procedures. No injuries have been reported in connection with this defect.

The affected probes were distributed worldwide, including across the United States and Canada. Facilities using this model should identify affected units by their serial numbers and take preventive action.

Healthcare providers should conduct visual inspections of the probe before and after sterilization, disinfection, or cleaning, and before and after each intraoperative procedure. Any problems should be reported to Hitachi Healthcare Americas Corporation and to the FDA.

The recalled product

Product

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

Manufacturer

Hitachi Healthcare Americas Corporation

Category

Medical Device — Surgical Ultrasound Equipment

Hazard

• hardware-defect
• sterile-field-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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