VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
Summary
The FDA issued a Class I for VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for by Ventec Life Systems, Inc.. Reason: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of v.
Details
Source
Device Recall
External ID
Z-0127-2027
Action Date
2026-10-28
Status
Ongoing
Category
device
Product Description
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
Lot/Code Info: All Serial Numbers: UDI: 00850018761130
Quantity Affected: 100 units
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.
Distribution
Distribution US nationwide including Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-17
Company
Bothell, WA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 187 device recalls issued in the same week, part of 480 device-related FDA actions this month.
Ventec Life Systems, Inc. has 19 FDA actions in our database, including 19 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ventec Life Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ventec Life Systems, Inc. have FDA actions?
Ventec Life Systems, Inc. has 19 FDA actions in our database, including 19 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0127-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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