Recall Z-0693-2024 ยท CBK Ventilator, Continuous, Facility Use
Percussionaire Corporation
Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
| Date | Jan 17, 2024 (initiated Mar 28, 2023) |
| Status | Open, Classified |
| 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 |
| Quantity | 195 |
| Distribution | US: RI, CA, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905235 | VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS Percussionaire Corp., May 3, 1991 |