Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Distal Phasitron Kit, part S20020

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall Distal Phasitron Kit, part S20020see related information
Date Initiated by FirmMarch 28, 2023
Date PostedJanuary 17, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0693-2024
Recall Event ID 93648
510(K)NumberK905235 
Product Classification Ventilator, continuous, facility use - Product Code CBK
ProductDistal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Code Information UDI-DI: 00849436000693, Lots/Expiration: WO03739/September 13, 2024, and WO04218/November 14, 2024.
Recalling Firm/
Manufacturer		 Percussionaire Corporation
130 Mcghee Rd Ste 109
Sandpoint ID 83864-8409
For Additional Information Contact
208-263-2549
Manufacturer Reason
for Recall		Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
FDA Determined
Cause 2		Process control
ActionOn 3/28/23, correction notices were emailed to customers who were asked to remove and switch the reservoir bag to the proper location. On 1/24/24, follow-up correction notices were sent to customers who were asked to do the following: 1) Review your inventory, and if affected devices are identified, ensure the reservoir bag is in the proper location. 2) If affected devices were further distributed, send a copy of this notice to your customers. 3) Complete and return the Effectiveness Check Questionnaire via email to customerservice.us@sentec.com If you have any questions, contact the firm's Customer Service at customerservice.us@sentec.com or by phone at (208)- 263- 2549 Monday - Friday from 7 AM to 3:30 PM (PST). Additional information for contact information can be found at www.sentec.com/contact
Quantity in Commerce195
DistributionUS: RI, CA, TX
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
-
-