VOCSN+Pro Respiratory System Backup Battery Alarm Failure Recall
Ventec Life Systems is recalling VOCSN+Pro respiratory systems due to a damaged backup battery that may prevent the backup alarm from activating during power loss, delaying caregiver awareness of a hazardous condition.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: This is an FDA Class II recall for a respiratory support device where the failure of a backup safety alarm could result in delayed detection of a hazardous condition in patients dependent on the device, meeting the Severe criteria for a medical device with risk of serious patient harm.
Plain-English summary
Ventec Life Systems, Inc. is recalling the VOCSN+Pro respiratory system (Model REF: PRT-00853-000 package and REF: PRT-00490-001 unit) because the device may have a damaged backup battery that supports the backup alarm function. If the backup battery is damaged, the backup alarm may not activate during a loss of primary power and absence or depletion of backup power sources.
The failure of the backup alarm to activate could result in delayed caregiver awareness of a hazardous condition. The affected devices were distributed nationwide in Utah.
If you are using a VOCSN+Pro respiratory system, contact Ventec Life Systems, Inc. immediately for instructions. Do not continue using a device with a potentially damaged backup battery without first contacting the manufacturer.
The recalled product
- Product
- VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
- Manufacturer
- Ventec Life Systems, Inc.
- Affected units
- 1
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)
- REF/UDI-DI/Serial Number/Lot: PRT-00853-000/00855573007839/155391P/807138
- PRT-00490-001/00855573007792/155391/804613
Distribution
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