HysteroLux Fluid Management System recall: software anomaly
In plain language
This recall involves the HysteroLux Fluid Management System sold in Canada. It's being recalled because a software anomaly can cause the inflow volume display to freeze during long procedures, potentially leading to too much fluid entering a patient's circulatory system. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model number 72205000 and all serial numbers.
- Contact W.O.M. WORLD OF MEDICINE GmbH for further instructions.
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Affected products
HysteroLux Fluid Management System
Model: 72205000
Lot: All serial numbers
Why this matters
Risk of distension fluid reaching patient's circulatory system
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: All serial numbers
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 72205000
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Risk of distension fluid reaching patient's circulatory system
What should consumers do?
Stop using the product immediately. Check model number 72205000 and all serial numbers. Contact W.O.M. WORLD OF MEDICINE GmbH for further instructions.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Risk of distension fluid reaching patient's circulatory system
When was this product recalled?
This product was recalled on December 11, 2020.
Is the HysteroLux brand affected by this recall?
Yes, HysteroLux products are affected by this recall. This recall involves the HysteroLux Fluid Management System sold in Canada. It's being recalled because a software anomaly can cause the inflow volume display to freeze during long procedures, potentially leading to too much fluid entering a patient's circulatory system. Stop using the product and follow the return/repair steps in the official notice.