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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 6 of 6 Results
510(K) Number: K142679
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Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b... 1 06/06/2022 GE Healthcare, LLC
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr®om C... 1 06/06/2022 GE Healthcare, LLC
CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically... 2 08/24/2020 GE Healthcare, LLC
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) ... 1 11/30/2018 GE Healthcare, LLC
The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO an... 2 08/08/2018 Datex-Ohmeda, Inc.
CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventil... 2 06/01/2018 Datex-Ohmeda, Inc.