Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
FDA device recall Z-0693-2024 · posted 2024-01-17 · Open, Classified
Recall details
- Recalling firm
- Percussionaire Corporation
- Reason for recall
- Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
- Action taken
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- CBK
- Quantity affected
- 195
- Distribution
- US: RI, CA, TX
- Date initiated
- 2023-03-28
- Date posted
- 2024-01-17
- Location
- Sandpoint, ID
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS (K905235) | Percussionaire Corp. | 1991-05-03 |