The Recall Desk
HighFDA (Devices)·Z-0954-2020·Announced 2020-02-26

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.

What this means for you

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 involves a medical device with a defect that disables safety alarms, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.

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 access
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilator
Hazard
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 →

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