Distal Phasitron, Part: S20020, for use with Percussionaire… recallZ-0693-2024 · Percussionaire Corporation · initiated Mar 28, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Percussionaire Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
FDA root cause category: Process control
What the company is doing
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 [email protected] If you have any questions, contact the firm's Customer Service at [email protected] 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
Recall details
- Recall number
- Z-0693-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 28, 2023
- Posted by the FDA
- Jan 17, 2024
- Recalling firm
- Percussionaire Corporation
- Quantity
- 195
- Product code
- CBK
- FDA submissions
- K905235
- Distribution
- US: RI, CA, TX
Product description
Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Code information (models, lots, serial numbers)
UDI-DI: 00849436000693, Lots/Expiration: WO03739/September 13, 2024, and WO04218/November 14, 2024.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Percussionaire S20020Percussionaire Corporation · Ventilator, Continuous, Facility Use1 recall0 reports
Other devices under the same FDA submission
6 devices cleared under K905235 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Percussionaire F00007-1Percussionaire Corporation · Ventilator, Continuous, Facility Use1 recall16 reports
- Percussionaire A50605-DPercussionaire Corporation · Ventilator, Continuous, Facility Use1 recall5 reports
- Percussionaire A50094-DPercussionaire Corporation · Ventilator, Continuous, Facility Use1 recall4 reports
- Percussionaire F00008-1Percussionaire Corporation · Ventilator, Continuous, Facility Use5 reports
- Percussionaire F00038-2Percussionaire Corporation · Ventilator, Continuous, Facility Use3 reports
- Percussionaire F00008-1Percussionaire Corporation · Ventilator, Continuous, Facility Use1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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