Z-2288-2021Class II

Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B...

Name: Z-2288-2021 Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B...
Creator: Philips Respironics, Inc.
Published: 2021-07-26
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2021-07-26 / Open, Classified / root cause: labeling and UDI

FDA source

Philips Respironics, Inc. began a recall of Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19... on 2021-07-26. FDA classified it as Class II and gives the reason as "Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2288-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-07-26
Posted: 2021-08-13
Recalling firm: Respironics, Inc.
Product: Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
Product code: NOU Continuous, Ventilator, Home Use
Reason for recall: Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On July 26, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were advised of the two software issues that the firm had identified related to pressure increase. Customers received guidance on how to identify affected products: Devices with software versions devices with software versions 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01 and 1.06.02 are impacted. Customers were provided with actions to take until the upcoming software fix is implemented on your device. Philips will be releasing a software correction to resolve this issue, and will contact customers when the software correction is released. If you need any further information or support concerning this issue, please contact Philips Customer Care Solutions Center Trilogy Evo: +1-800-345-6443 Option 2, Option 1 (Available 24/7) Trilogy EV300: +1-800-722-9377 (Available 24/7)
Quantity in commerce: 101 (FEMA Stockpile Only); 21077 (OUS)
Distribution: Worldwide distribution - US nationwide distribution.
Product codes and lots: Software version numbers 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, and 1.06.02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2288-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2287-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-13
Z-2288-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-13
Z-2289-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-13
Z-2290-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-13

Product code NOU

K181166Class IITrilogy EvoRespironics, Inc. / cleared 2019-07-18

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 2026-09-05. View this recall on fda.gov (opens on fda.gov)