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.
What this means for you
Illness, injury, or structural failure has been reported. 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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