Hitachi L43K intraoperative probe recall: screw cover may detach during sterilization
Hitachi Healthcare is recalling 120 Model L43K intraoperative probes because the screw cover at the probe tip may fall off after cleaning and sterilization. Facilities should inspect probes before and after sterilization and before and after each surgical use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with a documented mechanical defect that poses a risk of harm in sterile surgical field environments. However, no injuries or illnesses have been reported, making this a risk-of-harm product without reported injury.
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
- 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.
Lot numbers (20)
- Serial Numbers: 20504835
- 20504836
- 20504837
- 20504838
- 20504839
- 20556338
- 20556369
- 20556370
- 20615320
- 20615321
- 20639217
- 20639218
- 20639219
- 20639223
- 20639224
- 20639225
- 20639226
- 20639230
- 20665290
- 20693154
Distribution
Distributed nationwide across the United States.
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