Hamilton Medical Inc, Reno, Nev, is initiating a nationwide voluntary recall of 47 RAPHAEL ventilators with older generation software. Current RAPHAEL Color and RAPHAEL XTC ventilators are not affected by this action. Only four customer facilities have been impacted by this action. Hamilton Medical has already contacted these facilities regarding immediate field corrections.
This voluntary recall is being conducted because the RAPHAEL ventilator, under certain very specific conditions following an oxygen cell calibration without a compressed air supply, as instructed in the RAPHAEL Operator’s Manual, can be put into a state where no visible or audible alarms are triggered. Hamilton Medical investigated a single complaint and found that a software algorithm designed to suppress false positive alarms may preclude any alarm under this scenario. “It should be noted,” said David Costa, vice president for Hamilton Medical, “that the oxygen cell calibration is intended to be performed while the RAPHAEL is connected to both air and oxygen high pressure gas sources. In the reported incident, this was not the case”.
The following RAPHAEL ventilators are affected:
RAPHAEL (Software version 2.2x)
RAPHAEL Silver (Software version 2.2xS)
RAPHAEL Color (Software version 2.2xC, 2.2xCU)
Customers who have product affected by this recall should (1) verify the proper function of their devices as described in Section 3 of the RAPHAEL Operator’s Manual, (2) attach a caution sticker to the ventilator advising the clinician to check the LowMinVol alarm after oxygen cell calibration and (3) change their in-house test procedures for oxygen calibration as indicated in the corrective action package supplied to each affected user. Copies of this information are available from the company although each customer affected has already been contacted and this information has been forwarded. The ventilators may continue to be used after these steps are complete.
Hamilton Medical Inc has also arranged for all customer units affected by this action to receive new current generation software at no charge, that will not only eliminate this problem but also provide customers with noninvasive ventilation (NIV) and with tubing resistance compliance (TRC) along with a bi-directional apnea back-up among other enhancements.