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U.S. Department of Health and Human Services

Class 2 Device Recall VOCSNPro

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 Class 2 Device Recall VOCSNProsee related information
Date Initiated by FirmMay 08, 2026
Date PostedJune 23, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2525-2026
Recall Event ID 98888
510(K)NumberK162877 
Product Classification Ventilator, continuous, facility use - Product Code CBK
ProductVOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Code Information REF/UDI-DI/Serial Number/Lot: PRT-00853-000/00855573007839/155391P/807138, PRT-00490-001/00855573007792/155391/804613
FEI Number 3013095415
Recalling Firm/
Manufacturer		 Ventec Life Systems, Inc.
22002 26th Ave Se
Bothell WA 98021-4903
For Additional Information Contact
425-686-1722
Manufacturer Reason
for Recall		Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.
FDA Determined
Cause 2		Vendor change control
ActionOn 5/8/2026, recall notices were mailed to customers who were asked to do the following: 1) Immediately discontinue use of affected devices. 2) Inspect current stock, quarantine/segregate any unused affected products, remove affected devices from clinical service and segregate to prevent further use. 3) Use an unaffected ventilator for patient support. 4) If you have distributed or transferred affected devices to other facilities, caregivers, or end users, you must promptly notify them of this recall and provide a copy of this notification. 5) Confirm receipt of this notification letter by returning the enclosed Customer Response Form via email to Ventec-Recall@reacthealth.com Upon receipt of the Customer Response Form, firm will arrange for repair of existing device(s). Return the affected product to React Health If you have any questions, please contact firm at 844-698-6276.
Quantity in Commerce1
DistributionUS Nationwide distribution in the state of UT.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CBK
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