Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Recall
- Recall Number
- Z-0693-2024
- Event Number
- 93648
- Firm
- Percussionaire Corporation
- FEI Number
- 1000524541
- Product Code
- CBK
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- March 28, 2023
- Posted
- January 17, 2024
- Address
- 130 Mcghee Rd, Ste 109, Sandpoint, ID, 83864-8409
Description
Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
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
US: RI, CA, TX
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