Recall Z-0020-2013 ยท BSZ Gas-Machine, Anesthesia
Accutron Inc
Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine.
| Date | Oct 9, 2012 (initiated Apr 29, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Accutron sent an Urgent Advisory Notice letter dated April 6, 2012 to all their customers who purchased the Ultra PC% Cabinet Mount Flowmeter. The letter informed the customers of the problem identified and actions to be taken. Customers were instructed to discontinue use or to continue use of the device only with extreme care until a replacement can be installed. Extreme care includes the use of the titration method for nitrous oxide administration coupled with close monitoring of both the patient and the actual gas flow through the flowtubes. For question contact Accutron at (800) 531-2 |
| Quantity | 220 units total |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052335 | ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA Accutron, Inc., Nov 23, 2005 |