The Maquet SERVO-i ventilator battery module has been recalled due to the battery having a shorter run time than expected, according to the American Society of Anesthesiologists.
The FDA assigned a Class 1 recall, the agency's most serious warning, because the sudden shutdown can result in serious health consequences or death. The malfunction has been found in models distributed after Jan. 31, 2010, and the recall includes more than 90,000 battery modules.
The SERVO-i is used in conjunction with the SERVO-i ventilator during intra-hospital transportation to monitor patients with respiratory failure.
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The FDA assigned a Class 1 recall, the agency's most serious warning, because the sudden shutdown can result in serious health consequences or death. The malfunction has been found in models distributed after Jan. 31, 2010, and the recall includes more than 90,000 battery modules. The SERVO-i is used in conjunction with the SERVO-i ventilator during intra-hospital transportation to monitor patients with respiratory failure.
More Articles on Anesthesia:
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FDA Approves Sedasys Computer-Assisted System for GI Propofol Sedation
Masimo Rainbow Respiratory Monitor Cleared by FDA for Pediatric Use