Z-0884-2023Class I

Philips Garbin Ventilator, Model Number 1058180B

Name: Z-0884-2023 Philips Garbin Ventilator, Model Number 1058180B
Creator: Philips Respironics, Inc.
Published: 2022-12-07
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2022-12-07 / Open, Classified / root cause: manufacturing process

FDA source

Philips Respironics, Inc. began a recall of Philips Garbin Ventilator, Model Number 1058180B on 2022-12-07. FDA classified it as Class I and gives the reason as "The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0884-2023
Classification: Class I
Status: Open, Classified
Initiated: 2022-12-07
Posted: 2023-01-06
Recalling firm: Respironics, Inc.
Product: Philips Garbin Ventilator, Model Number 1058180B
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Telephone calls and URGENT Medical Device Recall notification letters were distributed beginning 12/6/22. Actions you must take as a device owner or healthcare provider to prevent risks for patients. Device is on patients: For affected Trilogy 100 and Trilogy 200 devices that are on patients, ensure that your clinical assessment of the patients is up to date, reflecting the true acuity of the patients and their respiratory therapy requirements. Your patient may experience serious harm if their device malfunctions and immediate intervention is not available. Until Philips Respironics is able to correct this problem you must adhere to the instructions below. Further instructions are provided below for devices that are not on patients. For ventilator dependent patients: 1. Consider transitioning ventilator dependent patients to an alternative life-support ventilator if, as determined by the clinical assessment for the individual patient in consultation with the patient s healthcare provider, a malfunction would lead to serious injury if timely access to a backup ventilator is not possible. 2. Quarantine all impacted devices that are removed from service. 3. Please indicate which Serial Numbers must be removed from service in exchange for an alternative device For all other patients: 1. Ensure that device alarm settings are configured appropriately for your patient s needs, with special consideration for the alarms listed below. Ensure that alternative ventilation equipment is available, as appropriate to patient need, in case of emergency issues with alarms that cannot be resolved. 2. Ensure that backup monitoring is configured as required by the clinical assessment. Pulse oximetry, ECG, heart rate, blood pressure, or respiratory rate may provide additional advanced warning of and lead to faster intervention if hypoxemia were to occur. If these accessories are prescribed, ensure patients advised of proper use. 3. Consider using an inline bacterial filter which ma
Quantity in commerce: 9
Distribution: US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America.
Product codes and lots: UDI: 00606959429338; Serial Numbers: GV119100314 GV118011626 GV117030343 GV117020301 GV11910210D GV117060237 GV11807062D GV119070802 GV11605061E

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0884-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0882-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06
Z-0883-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06
Z-0884-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06

Product code CBK

K083526Class IITrilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group / cleared 2009-03-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)