Agency classClass IOur severity:Severe FDA (Devices)·Z-2343-2015·Announced 2015-08-26

Draeger Evita Infinity V500 Ventilator Battery Recall

Draeger Medical is recalling 2,081 Evita Infinity V500 ventilators because the optional PS500 battery capacity did not last as long as expected.

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: "The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected."

Plain-English summary

Draeger Medical, Inc. is recalling 2,081 units of the PS500 of an IACS Workstation Critical Care (Evita Infinity V500). This medical device is intended for the ventilation of adult, pediatric, and neonatal patients. The affected units are identified by Catalog Numbers 8416400 and 8417400.

The recall was initiated because the battery capacity of the optional PS500 component did not last as long as expected. The source text does not specify the exact duration of the battery life or the specific impact on patient care.

The affected products were distributed nationwide. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units or what to do if they are currently in use.

The recalled product

Product: PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
Manufacturer: Draeger Medical, Inc.
Category: Medical Device — Ventilator
Hazard: battery-failure
Affected units: 2,081

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)

Catalog Number(s): 8416400
8417400

Distribution

Distributed nationwide across the United States.

Same manufacturer · Draeger Medical, Inc.

See all →

Severe
Draeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall
FDA (Devices) · 2024-12-25
Severe
FDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure
FDA (Devices) · 2024-12-25
Critical
Draeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
FDA (Devices) · 2024-11-20
Severe
Anesthesia workstation piston ventilator may fail before or during use
FDA (Devices) · 2024-11-20
Severe
Dräger Perseus A500 Anesthesia Workstation Recalled for Unexpected Battery-Power Shutdowns
FDA (Devices) · 2024-04-24

Same hazard · battery failure