Philips Respironics Recalls Trilogy and Garbin Ventilators Due to Software Issue
Philips Respironics is recalling approximately 104,508 Trilogy and Garbin ventilators due to a software issue. The recall covers units distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a software issue in life-support ventilators. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Philips Respironics has initiated a voluntary recall of specific Trilogy and Garbin ventilator models, including the Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, and Garbin Plus. These devices provide continuous or intermittent ventilatory support for individuals requiring mechanical ventilation. The recall affects approximately 104,508 units.
The reason for the recall is a software issue. The affected units were distributed nationwide, including Puerto Rico, and internationally to the US Virgin Islands. Affected units can be identified by an 11-digit serial number beginning with GV or TV, or the specific code TGY1D01463.
The recall was initiated on January 18, 2016, and was classified as Class II by the FDA. The recall status is currently terminated as of May 26, 2017. Consumers and healthcare providers should check their device serial numbers against the provided codes to determine if their unit is affected.
The recalled product
- Product
- Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
- Manufacturer
- Philips Respironics
- Category
- Medical Device — Ventilators
- Hazard
- Affected units
- 104,508
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 11 digit S/N begginning with GV or TV
- also TGY1D01463
Distribution
Related recalls
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- SevereRespironics Trilogy Ventilators Recalled for Faulty Power Supply Component
FDA (Devices) · 2012-08-01
- SeverePhillips Respironics Recalls Trilogy Ventilators Due to Power Board Defect
FDA (Devices) · 2014-03-12
- SevereTrilogy Evo Ventilator Recall Due to Potential Loss of Ventilation
FDA (Devices) · 2024-04-24
- SeverePhilips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
FDA (Devices) · 2020-02-26
- SeverePhilips Respironics Continuous Ventilators Recalled for Foam Degradation Risk
FDA (Devices) · 2021-07-21
- SeverePhilips Respironics respiratory ventilators recalled for foam degradation
FDA (Devices) · 2022-03-30