Ventec Ventilator Cable Recall Due to Potential Disconnection
Ventec Life Systems is recalling 930 ventilators because an internal cable may disconnect, causing system reboots and therapy interruption.
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 disconnection may interrupt ventilation therapy, a situation with a reasonable probability of causing serious adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Ventec Life Systems, Inc. is recalling 930 units of the VC ventilator (Model Number: PRT-01098-000, Package PN: PRT-01125-000). These devices are used for ventilatory support and were distributed nationwide in the United States, including Puerto Rico. The recall involves all units with UDI 00855573007730.
The recall is being conducted because the ventilator's internal flow transducer cable connector may disconnect from the internal board. This disconnection can potentially result in a system reboot and an interruption of ventilation therapy.
The source text does not report any illnesses, injuries, or deaths associated with this defect. Users of these devices should contact Ventec Life Systems, Inc. for further instructions on how to address the issue.
The recalled product
- Product
- VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.
- Manufacturer
- Ventec Life Systems, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 930
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 (1)
- All Serial Numbers: UDI: 00855573007730
Distribution
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