Z-3321-2026

Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used...

Name: Z-3321-2026 Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used...
Creator: Percussionaire Corporation
Published: 2026-08-18
License: https://open.fda.gov/license/

Percussionaire Corporation / initiated 2026-08-18 / Open, Classified

FDA source

Recall record

Recall number: Z-3321-2026
Status: Open, Classified
Initiated: 2026-08-18
Posted: 2026-09-28
Recalling firm: Percussionaire Corporation
Product: Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
Product code: NHJ Device, Positive Pressure Breathing, Intermittent
Reason for recall: Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
FDA root cause: Device Design
Action: On 8/18/2026, correction notices were emailed to customers and distributors who were informed of the following: The following warning will be added to associated Instructions for Use: Warning: Do not use IPV therapy in conjunction with volatile anesthetic delivery systems. The high-frequency percussive flow generated during IPV therapy may alter the controlled delivery of volatile anesthetic agents within the breathing circuit, resulting in unpredictable anesthetic agent concentrations that may result in serious patient harm. Note: Consult the anesthesia healthcare provider before disconnecting from the system if considering delivering IPV directly to the patient's airway. Customers were asked to do the following: 1) Print and post the new warning for applicable IPV devices throughout your facility to ensure adequate distribution of new information to users. 2) Reinforce adherence to the IPV User Guide and IPV Quick Reference Guide instructions, including ensuring communication and training primary users of IPV therapy, specifically those using it in-line with a ventilator, on the instructions and new warning. Distributors were asked to do the following: - Translate (if applicable) and send the Urgent Medical Device Field Safety Notice to affected end customers. -If the Distributor receives the signed acknowledgement letters from affected customers, please forward them and all related communication to [email protected]. If there are any additional questions related to the updated instructions or other questions, please contact [email protected]
Quantity in commerce: 229,105
Distribution: Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI and the countries of Canada, Belgium, Chile, France, Germany, Israel, Italy, Latvia, Netherlands, Norway, Oman, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Kuwait, Australia, South Africa.
Product codes and lots: Product Number/UDI-DI: S00002-C/00849436000020, 00849436000563, 00849436000570, 00849436000143, 00849436000648; P5/00849436000501; Instruction Manual: P20045 Rev B

Product code NHJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-02. View this recall on fda.gov (opens on fda.gov)