Recall record at a glance
| Official record | Z-1824-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Spacelabs Healthcare Inc. |
| Report date | Jun 25, 2014 |
| Recall initiation date | May 9, 2014 |
| Quantity | 46 units distributed within the US; 108 units distributed outside the US. |
| Location | Snoqualmie, WA, United States |
Official product description
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
Why the product was recalled
Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.
Distribution information
Worldwide Distribution-USA (nationwide) including the states of AZ, IN, LA, GA, SC, FL, and NY, and 18 customers outside the US.
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
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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