Device product
Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Z-0017-2013
Product summary
- Firm
- Accutron Inc
- Event
- Event 63174
- Status
- Terminated
- Classification
- Class I
- Quantity
- 220 units total
- Official record key
device-enforcement:Z-0017-2013
Official wording
Reason: Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
Code information: Model#27025: Lot # 73971, 74929. Model#31970: Lot#74142.
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.