| Class 2 Device Recall Mindray |  |
Date Initiated by Firm | July 22, 2024 |
Date Posted | September 04, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2952-2024 |
Recall Event ID |
95099 |
510(K)Number | K201957 |
Product Classification |
Gas-machine, anesthesia - Product Code BSZ
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Product | Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system.
Part Number: Part Number115-066759-00 |
Code Information |
UDI-DI:06936415975760
Serial Number:
AH6C25000263
AH6C25000255
AH6C27000355
AH6C27000346
AH6C27000371
AH6C25000256
AH6C25000296
AH6C25000290
AH6C27000361
AH6C25000254
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
|
Recalling Firm/ Manufacturer |
Mindray DS USA, Inc. dba Mindray North America 800 Macarthur Blvd Mahwah NJ 07430-2001
|
For Additional Information Contact | SAME 800-288-2121 |
Manufacturer Reason for Recall | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the
patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe
cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Mindray issued an "URGENT Medical Device Recall" letter on July 22, 2024. Letter states reason for recall, health risk and actions to be taken:
The V90 electronic vaporizer can continue to be used normally. If "Vaporizer Output Abnormal" alarm or other alarms associated with abnormal vaporizer output or high anesthetic agent alarms occur during use, take appropriate intervention per the A9 Operators manual and contact Mindray Technical Support for assistance.
The intervention could be switching to another V90 electronic vaporizer, or the user can decide to switch to intravenous anesthesia.
For vaporizer replacement, refer to A9 Operators manual part number H-046-017199-00, section 3.4. Vaporizer . The manual is available on the Mindray website.
Mindray s Technical Support team can assist and may be reached at (877) 913-9663
(Option 1) Monday through Friday, 8:30 a.m. 5:30 p.m. ET.
Please ensure that applicable clinical staff are aware of the content of this letter.
Mindray will replace all affected V90 electronic vaporizers located at your facility.
The V90 electronic vaporizers will be shipped directly to your facility, and a Mindray Care Team representative will contact you to schedule the installation and collect the affected V90 electronic vaporizers
Contact:
Director, Quality Operations and Regulatory Affairs
US Agent for Shenzhen Mindray Biomedical Electronics Corp., Ltd
Mindray DS USA, Inc.
201.995.8407
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Quantity in Commerce | 96 units |
Distribution | US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada
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Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = BSZ
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