Philips Respironics Recalls LifeVent EVO Ventilators Due to Software Alarm Defect
Philips Respironics is recalling 29 LifeVent EVO ventilators because a software defect causes the loss of all power alarms.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected…"
Plain-English summary
Philips Respironics, Inc. is recalling 29 units of the LifeVent EVO Ventilator (Model Number SP2100X26B) due to a software defect. The affected software versions are SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00. This defect results in inoperative and loss of all power alarms, causing incorrect or unexpected results that fail specific safety requirements.
The recall involves 29 specific serial numbers distributed to countries outside the United States, including Germany, France, Italy, and the United Kingdom. The source text does not report any illnesses or injuries associated with this defect.
Healthcare providers and facilities should identify affected units by checking the model and serial numbers against the provided list. Users should contact Philips Respironics for instructions on how to resolve the software defect.
The recalled product
- Product
- LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate…
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 29
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 (20)
- Model/Material Number: SP2100X26B Serial Numbers: H25538574D9D9
- H256917933B78
- H2569193868C0
- H2569196907F1
- H25691987749F
- H256920522A99
- H2569224829A3
- H256924542CCE
- H256925062BB8
- H25692591881F
- H25692661E4B3
- H25692712C1FC
- H25692910F2F5
- H25692952B687
- H256930400CE8
- H25693118A4C4
- H2569421090C9
- H256943094E0C
- H25755370F165
- H25755371E0EC
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 13 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
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