Z-0131-2027

VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support

Name: Z-0131-2027 VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support
Creator: Ventec Life Systems, Inc.
Published: 2026-09-17
License: https://open.fda.gov/license/

Ventec Life Systems, Inc. / initiated 2026-09-17 / Open, Classified

FDA source

Recall record

Recall number: Z-0131-2027
Status: Open, Classified
Initiated: 2026-09-17
Posted: 2026-10-20
Recalling firm: Ventec Life Systems, Inc.
Product: VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.
Product code: CBK Ventilator, Continuous, Facility Use
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 root cause: Under Investigation by firm
Action: On 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 commerce: 180 units
Distribution: Distribution US nationwide including Puerto Rico.
Product codes and lots: All Serial Numbers: UDI: 00850018761116

Product code CBK

K162877Class IIVOCSN Unified Respiratory SystemVentec Life Systems, Inc. / cleared 2017-04-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-10-23. View this recall on fda.gov (opens on fda.gov)