Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who
Summary
The FDA issued a Class II for Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory by Breas Medical, Inc.. Reason: A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilat.
Details
Source
Device Recall
External ID
Z-1382-2022
Action Date
2022-07-20
Status
Ongoing
Category
device
Product Description
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier
Lot/Code Info: Unique Device Identifier (UDI): UDI 07321822300004. Serial number ranges in scope are: D******, K******, M01**** to M040124, where asterisk (*) denotes a digit from 0 to 9.
Quantity Affected: 1,113 units
Reason for Recall
A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-02
Company
North Billerica, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Breas Medical, Inc. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Breas Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Breas Medical, Inc. have FDA actions?
Breas Medical, Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1382-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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