Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596, 13597, 13598, 13599, 13600, 13602,
FDA device recall Z-0018-2013 · posted 2012-10-09 · Terminated
Recall details
- Recalling firm
- Accutron Inc
- Reason for recall
- 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.
- Action taken
- 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) 531-2221 or by email at jheadrick@accutron-inc.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 220 units total
- Distribution
- US Nationwide Distribution
- Date initiated
- 2012-04-29
- Date posted
- 2012-10-09
- Date terminated
- 2013-02-01
- Location
- Phoenix, AZ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA (K052335) | Accutron, Inc. | 2005-11-23 |