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Recall Observatory FDA recall evidence

Device product

Isoflurane (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.

Z-0721-2026

October 20, 2025

Class II

Product summary

Firm
Mindray DS USA, Inc. dba Mindray North America
Event
Event 97810
Status
Ongoing
Classification
Class II
Quantity
54 units
Official record key
device-enforcement:Z-0721-2026

Official wording

Reason: Potential for anesthesia leakage.

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.

Distribution pattern: Worldwide - 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for anesthesia leakage.