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U.S. Department of Health and Human Services

Class 2 Device Recall Isoflurane (ISO) V90 Electronic Vaporizer

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 Class 2 Device Recall Isoflurane (ISO) V90 Electronic Vaporizersee related information
Date Initiated by FirmOctober 20, 2025
Date PostedNovember 26, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0721-2026
Recall Event ID 97810
510(K)NumberK201957 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductIsoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.
Code Information 1. 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, AH6B44000673, AH6B44000705, AH6B44000706, AH6B44000707, AH6B44000708, AH6B44000709, AH6B44000710, AH6B44000711, AH6B44000712, AH6B44000713, AH6B44000715, AH6B44000716, AH6B44000718, AH6B44000723, AH6B44000725, AH6B44000726, AH6B44000727, AH6B44000728, AH6B44000729, AH6B44000730, AH6B44000731, AH6B44000783, AH6B44000787, AH6B44000790, AH6B45000839, AH6B45000854, AH6B44000732, AH6B45000856, AH6B44000789, AH6B45000842, AH6B45000841, AH6B45000845, AH6B45000850, AH6B45000852, AH6B45000853. 2. Part Number E115-066758-00; 06936415975753; Serial Number: AH6B44000672.
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. dba Mindray North America
800 Macarthur Blvd
Mahwah NJ 07430-2001
For Additional Information ContactJames Clifford
+1-201-9958407
Manufacturer Reason
for Recall		Potential for anesthesia leakage.
FDA Determined
Cause 2		Device Design
ActionMindray notified consignees on about 10/20/2025 via letter. Consignees were informed that they could continue using the units as normal, but if an anesthetic odor or leak is detected, contact Mindray Technical Support. Interventions may include switching to another V90 vaporizer or using intravenous anesthesia as clinically appropriate. For vaporizer replacement procedures, refer to A9 Operator s Manual (Part No. H-046-017199-00, Section 3.4 Vaporizer ), available on the Mindray website. Mindray s Technical Support team can assist and may be reached at (877) 913-9663 (Option 2) Monday through Friday, 8:30 a.m. 5:30 p.m. ET. Consignees were instructed to complete and return the Acknowledgement and Receipt form provided, ensure that all applicable clinical staff are aware of the issue and maintain a copy of the recall notification with affected units or IFUs. Additionally, they were instructed to notify any organization to which the affected V90 electronic vaporizers identified have been distributed. The Mindray Care Team will contact consignees to arrange the replacement of all affected SEVO and ISO V90 electronic vaporizers located at their facility. The V90 electronic vaporizers will be shipped directly to each facility, and a Mindray Care Team representative will schedule the installation and collect the affected V90 electronic vaporizers.
Quantity in Commerce54 units
DistributionWorldwide - US Nationwide distribution in the states of California, Florida, Georgia, Kentucky, Maryland, Mississippi, Missouri, New Jersey, Puerto Rico, Texas, Washington, West Virginia and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BSZ
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