Mindray DS USA recalled 54 Isoflurane V90 Vaporizers used with the A9 Anesthesia System, distributed worldwide to healthcare providers. The devices have a potential for anesthesia leakage. Clinicians should stop using immediately and contact Mindray DS USA for instructions.
Potential for anesthesia leakage.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Mindray DS USA, Inc. dba Mindray North America or your healthcare provider for instructions. Notification method: Letter
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The Isoflurane V90 Electronic Vaporizer is part of the A9 Anesthesia System used to deliver inhaled anesthetic agents during patient care. The system relies on vaporizers to regulate anesthetic delivery.
A potential leakage of anesthesia agent from the vaporizer could expose patients and healthcare personnel to the chemical.
This recall is not part of a broader industry pattern.
The recall affects 54 units distributed globally to healthcare facilities. Immediate cessation of use is advised to minimize exposure risk and guide facilities through recall procedures.
Identifiers are located on the Iso E_Vap adapter and related A9 System labeling. The recall notice lists exact serial numbers and part numbers.
Timeline for refunds or replacements not specified in the recall notice.
Keep a copy of the recall notice, record device Part Number 115-066758-00 and serial numbers, document communications with Mindray and healthcare providers, and maintain replacement records.
- Part Number 115-066758-00 - DI 06936415975753 - Serial Numbers: AH6B44000714, AH6B44000719, AH6B44000722, AH6B44000724, AH6B44000733, AH6B44000734, AH6B44000782, AH6B45000836, AH6B45000837, AH6B45000840, AH6B45000844, AH6B45000858, AH6B44000717, AH6B44000786, AH6B44000785, AH6B44000788, AH6B45000859, AH6B44000671 - 54 units - Distribution: Worldwide; US states listed include California, Florida, Georgia, Kentucky, Maryland, Mississippi, Missouri, New Jersey, Puerto Rico, Texas, Washington, West Virginia and Canada.
No injuries or incidents have been reported.
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