Recall record at a glance
| Official record | Z-1429-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Hamilton Medical AG |
| Report date | May 3, 2023 |
| Recall initiation date | Mar 14, 2023 |
| Quantity | 103 |
| Location | Bonaduz, N/A, Switzerland |
Official product description
HAMILTON-C6, REF: 160021
Why the product was recalled
Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.
Distribution information
US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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