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U.S. Department of Health and Human Services

Class 1 Device Recall VCSNPro

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 Class 1 Device Recall VCSNProsee related information
Date Initiated by FirmSeptember 17, 2026
Date PostedOctober 20, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0128-2027
Recall Event ID 99835
510(K)NumberK162877 
Product Classification Ventilator, continuous, facility use - Product Code CBK
ProductVCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support.
Code Information All Serial Numbers: UDI: 00855573007860
FEI Number 3013095415
Recalling Firm/
Manufacturer		 Ventec Life Systems, Inc.
22002 26th Ave Se
Bothell WA 98021-4903
For Additional Information ContactReact Health
844-698-6276
Manufacturer Reason
for Recall		Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn September 17, 2026, Ventec Life Systems Inc. dba React Health issued a Urgent: Medical Device Recall Notification via certified mail. Ventec ask consignees to take the following actions: 1.Review the customer communication and follow the applicable Actions to be Taken section. 2. Confirm receipt of this notification letter by returning the enclosed Customer Response Form to React Health via email, mail or use the online customer response form within 7 days. 3. If you have distributed or transferred affected devices to other facilities, caregivers, or end users, you must promptly notify them and provide a copy of this notification.
Quantity in Commerce4,368 units
DistributionDistribution US nationwide including Puerto Rico.
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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