Recall Z-2266-2018
Datex-Ohmeda, Inc. · initiated December 8, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume. Additional respiratory gas monitoring capabilities are supported through the use of optional GE patient monitoring modules. Not all features are available for all patient types or product configurations. The CARESCAPE R860 ventilator is not a pulmonary function calculation device. The system is designed for facility use, including within facility transport, and should only be used under the orders of a clinician.
Codes / lots: 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, CBRW00419, CBRW00424, CBRW00441, CBRW00443, CBRW00458, CBRW00460, CBRW00461, CBRW02306, CBRW02627, CBRW02629, 103721436, CBRU02450, CBRW01735, CBRW01044, CBRW01048, CBRW01049, CBRW01051, CBRW01052, CBRW01053, CBRW01056, CBRW01057, CBRW01059, CBRW01061, CBRW01062, CBRW01063, CBRW01075, CBRW01076, CBRW01077, CBRW01232, CBRW01814, CBRW01410, CBRW01412, 103798917, CBRW01918, CBRV02578, CBRW02442, CBRW02449, CBRW01830, CBRW01833, CBRW01838, CBRW01839, CBRW01849, CBRW01860, CBRW01889, CBRW01895, CBRW01896, CBRW01897, CBRW01898, CBRW01899, CBRW01900, CBRW01902, CBRW01903, CBRW01904, CBRW01905, CBRW01906, CBRW01909, CBRW01932, CBRV01459, 103730032, 103721104, CBRW01244, CBRW02420, CBRW01347, 103771244, CBRW02661, CBRU02452, 11495021, 70175736-1, 70175736-10, 70175736-100, 70175736-101, 70175736-102, 70175736-103, 70175736-104, 70175736-105, 70175736-106, 70175736-107, 70175736-108, 70175736-109, 70175736-11, 70175736-110, 70175736-111, 70175736-112…
Reason for recall
Potential for the display processor to experience an unexpected failure.
FDA-determined cause: Software change control
Action taken
On December 12, 2017 GE Healthcare sent letters to their consignees stating that There is a potential for the display processor to experience an unexpected failure. If this failure occurs, the device screen will temporarily go blank and will then display an Error Code EC01 XX. The blank display results in loss of monitored data being displayed to the user. There have been no injuries reported as a result of this issue. You may continue to use the system. Device performance is not affected on devices where no such display failure occurs. In the event this issue occurs, an audible alarm will sound. Mechanical ventilation will continue at previous settings. A device restart is required to clear the alarm condition. Consider using appropriate alternative means of ventilation such as a self-inflating bag or another ventilator to prevent patient injury while restarting the device. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Details
- Recall number
- Z-2266-2018
- Initiated
- December 8, 2017
- Posted by FDA
- June 1, 2018
- Terminated
- April 29, 2021
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Quantity
- 349 (US) + 2,051 (OUS)
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AZ, CA, GA, ID, IL, IN, MS, NC, NJ, NK, NV, OH, OK, RI, TX, and WI., and to the countries of : Albania, Argentina, Australia, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, El Salvador, Estonia, Ethiopia, Egypt…
- Recalling firm
- Datex-Ohmeda, Inc., Madison, WI