Z-2952-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2024
- Initiation Date
- July 22, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96 units
Product Description
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
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
Distribution Pattern
US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada
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