Nitric Oxide Delivery System Dosing Deficiency During Console Transitions
GENOSYL DS Nitric Oxide Delivery System is recalled for delivering below-intended doses during transitions between primary and backup consoles following a software update.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I designation requires a minimum severity score of 4. Although no illnesses or injuries are reported in the source, the dosing deficiency in a therapeutic nitric oxide delivery system represents a significant patient risk.
Plain-English summary
GENOSYL DS is a nitric oxide delivery system manufactured by Vero Biotech, LLC. The FDA recalls 465 units distributed nationwide due to a dosing deficiency.
The system delivers nitric oxide at doses below the intended level when transitioning between the primary console and backup console. This defect emerged following deployment of software version 2.2.3 to devices already in clinical use.
Affected units were distributed to healthcare facilities in Texas, Maryland, Virginia, Georgia, Florida, Kansas, Louisiana, Minnesota, and North Carolina. The recall identifies specific device serial numbers to enable healthcare providers to verify whether their equipment is involved.
The recalled product
- Product
- GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
- Manufacturer
- Vero Biotech, LLC
- Affected units
- 465
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)
- Model #: 601588-01
- Serial #'s: G0803
- G0807
- G0808
- G0814
- G0149
- G0157
- G0183
- G0191
- G0195
- G0198
- G0202
- G0560
- G0600
- G0693
- G0729
- G0734
- G0772
- G0775
- G0138
Distribution
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