Ventec Life Systems Recalls VOCSN+Pro Ventilators Due to Connector Defect
Ventec Life Systems is recalling 4,369 VOCSN+Pro ventilators because an internal cable connector may disconnect, causing system reboots and interruption of therapy.
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: The recall is classified as Class I because the internal cable connector may disconnect, potentially causing a system reboot and interruption of ventilation therapy. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Ventec Life Systems, Inc. is recalling 4,369 units of the VOCSN+Pro ventilator (Model Number: PRT-00490-001, Package PN: PRT-00853-000). The device is used for ventilatory support. The recall involves units with UDI codes 00855573007792 and 00855573007006.
The recall was initiated because the ventilator's internal flow transducer cable connector may disconnect from the internal board. This defect can potentially result in a system reboot and an interruption of ventilation therapy. The affected products were distributed nationwide in the United States, including Puerto Rico.
The source text does not report any illnesses, injuries, or deaths associated with this defect. Consumers and healthcare facilities should contact Ventec Life Systems for instructions on how to address the issue.
The recalled product
- Product
- VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.
- Manufacturer
- Ventec Life Systems, Inc.
- Category
- Medical Device — Ventilators
- Affected units
- 4,369
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 (2)
- All Serial Numbers: UDI: 00855573007792
- 00855573007006
Distribution
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