FDA Medical Device Recalls (openFDA)
Percussionaire Corporation: Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
- Recall number
- Z-0693-2024
- Recalling firm
- Percussionaire Corporation
- Product
- Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
- Status
- Open, Classified
- Initiated
- 2023-03-28
- Posted
- 2024-01-17
- Terminated
- not on file
- Reason
- Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
- Root cause
- Process control
- Action
- On 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
- 195
- Distribution
- US: RI, CA, TX
- Lot, serial or model codes
- UDI-DI: 00849436000693, Lots/Expiration: WO03739/September 13, 2024, and WO04218/November 14, 2024.
- 510(k) numbers
- ["K905235"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 1000524541
- Firm city
- Sandpoint
- Firm state
- ID
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28