Medical Device Recalls
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1 to 6 of 6 Results
510(K) Number: K142679 |
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Results per Page |
Product Description
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Recall
Class |
FDA Recall
Posting Date |
Recalling Firm
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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. |
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