Electrical Issue Sparks Anesthesia Machine Recall
4 Draeger Medical products affected, FDA reports.
Published: October 23, 2013
Four models from Draeger Medical's Fabius line of anesthesia machines have been voluntarily recalled by the company due to an electrical malfunction that could impair their operation, says the FDA.
The power supply on certain Fabius GS Premium, OS, Tiro and Tiro D-M machines lacked the minimum clearance between the electrical component and the unit housing, the company discovered, which could throw a complication into anesthesia providers' routine use.
"In extreme cases, the influence of mechanical forces — such as movement of the device, for example — may cause a failure of the automatic ventilation function of the device," Draeger reported. "If such a fault occurs, an audible and visual alarm is generated. Manual ventilation using the device is still possible and all other device functions remained unaffected." The company noted, however, that no failures or injuries had been reported.
The affected equipment was manufactured between February and May of this year, and distributed between March and June. Product codes and lot numbers are available on Draeger's website, and its customer service department can be reached at (800) 543-5047.
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