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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Monitoring Devices

Mindray DS USA, Inc. dba Mindray North America: V90 Electronic Vaporizers Recalled for Excessive Anesthetic Output

Agency Publication Date: September 4, 2024
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Summary

Mindray North America is recalling 218 units of its V90 electronic vaporizers used with A9 Anesthesia Systems because a faulty internal component may prevent a proper seal. This defect can cause the device to release more anesthetic agent than intended, leading to potentially dangerous concentrations during surgery. While the A9 system should trigger an alarm if this occurs, affected patients may experience vertigo, drowsiness, or long-term neurological issues like memory loss and inattention after their procedure.

Risk

An incomplete seal within the vaporizer allows anesthetic gas to bypass controls, delivering a higher dose than the medical professional set. This over-sedation can cause severe neurological sequelae, including hypomnesia (memory impairment) and difficulty maintaining attention.

What You Should Do

  1. Identify if your facility uses the Mindray A9 Anesthesia System and check the vaporizer for the following part numbers: 115-066755-00 (Sevoflurane Quik-Fil), 115-066756-00 (Sevoflurane Safety Filling), 115-066758-00 (Isoflurane Safety Filling), or 115-066759-00 (Desflurane Saf-T-Fill).
  2. Verify the serial numbers against the affected list, which includes specific codes such as AH6D28000517, AH6D28000518, AH6A28000471, AH6B24000165, and AH6C25000263 among others.
  3. Immediately contact Mindray North America at 800 Macarthur Blvd, Mahwah, New Jersey, or through their professional service channels to arrange for a technical inspection or repair.
  4. Monitor the A9 Anesthesia System closely during use for any 'abnormal vaporizer output' alarms which indicate this specific failure is occurring.
  5. Consult with your healthcare provider or facility biomedical engineering department regarding the continued use of these specific vaporizers until they have been serviced.
  6. Contact the FDA with any further safety concerns or to report adverse events at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer service and medical consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Sevoflurane E_Vap. (Quik-Fil) used with the A9 Anesthesia System
Model / REF:
115-066755-00
UPC Codes:
06936415975784
Lot Numbers:
AH6D28000517
AH6D28000518
Product: Sevoflurane E_Vap. (Safety Filling adapter) used with the A9 Anesthesia System
Model / REF:
115-066756-00
UPC Codes:
06936415975777
Lot Numbers:
AH6A28000471
AH6A24000202
AH6A28000474
AH6A27000378
AH6A28000466
AH6A24000195
AH6A28000457
AH6A25000237
AH6A28000426
AH6A24000199
AH6A24000207
Product: Isoflurane E_Vap. (Safety Filling adapter) used with the A9 Anesthesia System
Model / REF:
115-066758-00
UPC Codes:
06936415975753
Lot Numbers:
AH6B24000165
AH6B24000170
AH6B24000167
AH6B24000163
AH6B24000166
AH6B24000173
AH6B24000174
AH6B24000183
Product: Desflurane E_Vap. (Saf-T-Fill) used with the A9 Anesthesia System
Model / REF:
115-066759-00
UPC Codes:
06936415975760
Lot Numbers:
AH6C25000263
AH6C25000255
AH6C27000355
AH6C27000346
AH6C27000371
AH6C25000256
AH6C25000296
AH6C25000290
AH6C27000361
AH6C25000254
AH6C25000271
AH6C25000298
AH6C25000299
AH6C25000300
AH6C25000301
AH6C25000302
AH6C27000339
AH6C27000343
AH6C27000344
AH6C27000347
AH6C27000348
AH6C27000350
AH6C27000352
AH6C27000354
AH6C27000358
AH6C27000359
AH6C27000363
AH6C27000364
AH6C27000366
AH6C27000410
AH6C27000411
AH6C28000444
AH6C28000447
AH6C28000448
AH6C28000449
AH6C28000450
AH6C28000454

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95099
Status: Active
Manufacturer: Mindray DS USA, Inc. dba Mindray North America
Sold By: Direct distribution; Medical device distributors
Manufactured In: United States
Units Affected: 4 products (2 units; 96 units; 24 units; 96 units)
Distributed To: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.