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U.S. Department of Health and Human Services

Class 1 Device Recall Phasitron Breathing Circuit

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 Class 1 Device Recall Phasitron Breathing Circuitsee related information
Date Initiated by FirmDecember 23, 2024
Date PostedJanuary 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0960-2025
Recall Event ID 95979
510(K)NumberK905235 
Product Classification Ventilator, continuous, facility use - Product Code CBK
ProductVDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10 The Phasitron breathing circuit kit is intended to be used for continuous ventilation intended for controlled ventilation of patients
Code Information -Phasitron Kit, VDR, Single Patient, 5pk Model Number - A50094-D-5PK UDI-DI code: 00849436000259 Lot Codes: WO04294 WO04424 WO04764 WO05070 WO05186 WO05460 WO05685 WO05910 WO06388 WO06576 WO06883 WO07095 WO07196 WO07317 WO07405 WO07450 WO07696 - Control Unit Tester Model Number: A51001 VDR4 Lot Codes: WO04750 WO06701 - VDR W/Swivel T Single Patient Phasitron Model Number: PRT 991 Lot Code: WO04733 - VDR4 Humidification Adapter Kit, Case of 10 Model Number: PRT 992 Lot Code: WO045667 - VDR4 Humidification Kit with Cross Tee, Case of 10 Model Number: PRT 993 Lot Codes: WO04745 WO04832 WO04893 WO04893 WO05309 WO06523 WO07080 WO07283
Recalling Firm/
Manufacturer		 Percussionaire Corporation
130 Mcghee Rd Ste 109
Sandpoint ID 83864-8409
For Additional Information ContactRobert M. Cormier
877-425-8746
Manufacturer Reason
for Recall		Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
FDA Determined
Cause 2		Process control
ActionOn 12/23/2024, the firm sent an "Urgent Medical Device Notification" to customers informing them that due to recently becoming aware through one customer complaint that the venturi component transiently stopped oscillating while in use. The patient experienced a slight desaturation (low oxygen). When the Phasitron is stuck, the system continues to deliver pressures and volumes, but with reduced amplitude. The set values return when the venturi resumes oscillation. Customers are instructed to: 1. Please review all inventory for impacted lots referenced in the table below. 2. An enhanced Phasitron pre-use check has been developed to evaluate circuits for this issue which replaces the standard pre-use verification until affected products have been replaced at your facility. Please post the instructions provided in Appendix 2 in all areas of your facility. This enhanced pre-use check is to be completed for each new Phasitron breathing circuit in the lots identified below. 3. If product fails the pre-use check found in Appendix 2, DO NOT USE and dispose per your institutional protocol and contact FSCA@sentec.com for product exchange. 4. If a product malfunction is identified during use, please IMMEDIATELY STOP USE of the device and dispose according to your institutional protocol and contact FSCA@sentec.com for product exchange. 5. Complete and Return Acknowledgement form (see Appendix 1) after reviewing and implementing the requested actions by January 31, 2024. 6. After receipt of replacement product: o Dispose remaining product from affected lots per facility protocol. For any question, email FSCA@sentec.com.
Quantity in Commerce4,727 packs/cases
DistributionWorldwide - U.S. Nationwide distribution in the states of AZ, FL, IL, MS, MO, NE, NJ, NY, NC, RI, TX, UT, and WV. The countries of Belgium, Canada, France, Hong Kong, Netherlands, Russia, Switzerland and Turkey.
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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