Datex-Ohmeda CARESCAPE R860 Ventilators Recalled for Display Processor Failure
Datex-Ohmeda is recalling CARESCAPE R860 ventilators with software version 10SP05 because the display processor may experience unexpected failure.
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 involves a critical life-support medical device where a display processor failure could compromise patient monitoring and ventilation support, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Datex-Ohmeda, Inc. is recalling CARESCAPE R860 ventilators equipped with software version 10SP05. The recall is due to a potential for the display processor to experience an unexpected failure.
The affected devices are microprocessor-based, electronically controlled, pneumatically driven ventilators designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The system includes integrated monitoring of FiO2, airway pressure, flow, and volume.
A total of 349 units were distributed in the United States and 2,051 units were distributed outside the US. The recall covers distribution to specific US states and numerous countries worldwide. Healthcare facilities should check their inventory for the specific serial numbers listed in the official recall notice and contact the manufacturer for instructions on corrective action.
The recalled product
- Product
- CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a…
- Manufacturer
- Datex-Ohmeda, Inc.
- Category
- Medical Device — Ventilator
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)
- Lot / Serials #'s: 103841473
- 103725811-1
- 103725811-2
- CBRW01546
- CBRW01547
- CBRU02110
- CBRV00344
- CBRV02569
- CBRV00298
- 103721045
- 103808843
- CBRV03050
- CBRV03054
- CBRV03056
- CBRV03063
- CBRV03064
- CBRV03071
- CBRV03072
- CBRV03073
- CBRW00417
Distribution
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